--- title: "Maquet Cardiovascular, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Maquet Cardiovascular, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/maquet-cardiovascular-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Maquet Cardiovascular, LLC recall records **35** reported ongoing 38 records in this archive. Latest source date Jun 2, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 2, 2026 FDA device enforcement ### [The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA und...](https://isitonrecall.com/recall/fda-device-z-2741-2026-the-vasoview-hemopro-2-endoscopic-vessel-harvesting-system-model-vh-4000-udi-00607567700406-is-a-ste/) Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and Apr... Class II Reported ongoing Distribution: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR. [Official source for The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2741-2026%22) Aug 15, 2025 FDA device enforcement ### [Heartstring III Proximal Seal System. Intravascular anastomosis occluder.](https://isitonrecall.com/recall/fda-device-z-2586-2025-heartstring-iii-proximal-seal-system-intravascular-anastomosis-occluder/) Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Ger... [Official source for Heartstring III Proximal Seal System. Intravascular anastomosis occluder.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2586-2025%22) Aug 15, 2025 FDA device enforcement ### [Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.](https://isitonrecall.com/recall/fda-device-z-2587-2025-heartstring-iii-proximal-seal-system-3-8-mm-intravascular-anastomosis-occluder/) Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Ger... [Official source for Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2587-2025%22) Aug 15, 2025 FDA device enforcement ### [Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.](https://isitonrecall.com/recall/fda-device-z-2588-2025-heartstring-iii-proximal-seal-system-4-3-mm-intravascular-anastomosis-occluder/) Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Ger... [Official source for Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2588-2025%22) Aug 6, 2025 FDA device enforcement ### [Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a...](https://isitonrecall.com/recall/fda-device-z-2636-2025-vasoview-hemopro-3-endoscopic-vessel-harvesting-system-model-no-c-vh-6000-the-vasoview-hemopro-3-end/) Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heat... Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IL, MD & TX. [Official source for Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2636-2025%22) Mar 20, 2025 FDA device enforcement ### [The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens whi...](https://isitonrecall.com/recall/fda-device-z-1622-2025-the-vasoview-hemopro-2-endoscopic-vessel-harvesting-system-is-designed-for-use-in-conjunction-with-t/) There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that ... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand. [Official source for The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction wit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1622-2025%22) Mar 10, 2025 FDA device enforcement ### [Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).](https://isitonrecall.com/recall/fda-device-z-1577-2025-maquet-vh-3010-power-supply-used-to-deliver-power-to-the-harvesting-tool-of-the-vasoview-hemopro-evh/) Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, PR, TX, UT, VA, WI, WV and the countr... [Official source for Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1577-2025%22) Dec 9, 2024 FDA device enforcement ### [VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.](https://isitonrecall.com/recall/fda-device-z-0711-2025-vasoview-hemopro-2-endoscopic-vessel-harvesting-system-model-numbers-vh-4000-indicated-for-use-in-mi/) Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool Class I Reported ongoing Distribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Ho... [Official source for VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0711-2025%22) Dec 9, 2024 FDA device enforcement ### [Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvest...](https://isitonrecall.com/recall/fda-device-z-0712-2025-vasoview-hemopro-2-w-vasoshield-endoscopic-vessel-harvesting-system-model-numbers-vh-4001-indicated/) Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool Class I Reported ongoing Distribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Ho... [Official source for Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. In...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0712-2025%22) Oct 16, 2024 FDA device enforcement ### [Acrobat-i Positioner. Model Number C-XP-5000Z](https://isitonrecall.com/recall/fda-device-z-0484-2025-acrobat-i-positioner-model-number-c-xp-5000z/) Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. Class II Reported ongoing Distribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Re... [Official source for Acrobat-i Positioner. Model Number C-XP-5000Z](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0484-2025%22) Oct 16, 2024 FDA device enforcement ### [Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z](https://isitonrecall.com/recall/fda-device-z-0485-2025-acrobat-suv-vacuum-stabilizer-system-st-model-number-c-om-9000z/) Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. Class II Reported ongoing Distribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Re... [Official source for Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0485-2025%22) Oct 16, 2024 FDA device enforcement ### [Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z](https://isitonrecall.com/recall/fda-device-z-0486-2025-acrobat-i-vacuum-stabilizer-system-model-number-c-om-10000z/) Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. Class II Reported ongoing Distribution: Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Re... [Official source for Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0486-2025%22) Sep 20, 2024 FDA device enforcement ### [VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500](https://isitonrecall.com/recall/fda-device-z-0092-2025-vasoview-hemopro-endoscopic-vessel-harvesting-system-product-codes-vh-3000-w-and-vh-3500/) There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Reported ongoing Distribution: Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong. [Official source for VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0092-2025%22) May 31, 2024 FDA device enforcement ### [The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens whic...](https://isitonrecall.com/recall/fda-device-z-2337-2024-the-vasoview-hemopro-endoscopic-vessel-harvesting-systems-is-designed-for-use-in-conjunction-with-th/) There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than n... Class II Reported ongoing Distribution: NationwideForeign: AT DE DK ES GB HK IT NL ZA [Official source for The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2337-2024%22) May 31, 2024 FDA device enforcement ### [The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens whi...](https://isitonrecall.com/recall/fda-device-z-2338-2024-the-vasoview-hemopro-2-endoscopic-vessel-harvesting-system-is-designed-for-use-in-conjunction-with-t/) There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than n... Class II Reported ongoing Distribution: NationwideForeign: AT DE DK ES GB HK IT NL ZA [Official source for The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction wit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2338-2024%22) May 17, 2024 FDA device enforcement ### [The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model ...](https://isitonrecall.com/recall/fda-device-z-2175-2024-the-vasoview-hemopro-2-endoscopic-vessel-harvesting-system-labeled-as-the-following-1-vasoview-hemop/) Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United ... [Official source for The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2175-2024%22) May 17, 2024 FDA device enforcement ### [The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens whi...](https://isitonrecall.com/recall/fda-device-z-2176-2024-the-vasoview-hemopro-endoscopic-vessel-harvesting-systems-are-designed-for-use-in-conjunction-with-t/) Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United ... [Official source for The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction wit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2176-2024%22) Dec 13, 2023 FDA device enforcement ### [Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection](https://isitonrecall.com/recall/fda-device-z-0709-2024-product-ref-4000-100n-drain-express-single-w-ac-single-collection/) Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abs... Class I Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK [Official source for Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0709-2024%22) Dec 13, 2023 FDA device enforcement ### [Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit](https://isitonrecall.com/recall/fda-device-z-0710-2024-product-ref-4050-100n-drain-express-bru-w-ac-blood-recovery-unit/) Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abs... Class I Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK [Official source for Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0710-2024%22) Dec 1, 2023 FDA device enforcement ### [Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .](https://isitonrecall.com/recall/fda-device-z-0723-2024-vasoview-hemopro-endoscopic-vessel-harvesting-system-model-vh-3000-w/) Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or ... Class II Reported ongoing Distribution: US: OUS: China, Brazil, Hong Kong. [Official source for Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0723-2024%22) ## Reasons in these listed records - Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. - Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. - Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexe... - There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limite... These examples come from this result page and are not a ranking of every recall reason. ## Checking Maquet Cardiovascular, LLC ### Is there a recall on maquet cardiovascular, llc right now? This archive contains 38 records, including 35 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Maquet Cardiovascular, LLC](https://isitonrecall.com/check/?q=Maquet%20Cardiovascular%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)