--- title: "Medtronic Perfusion Systems Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Medtronic Perfusion Systems recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/medtronic-perfusion-systems/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Medtronic Perfusion Systems recall records **56** reported ongoing 56 records in this archive. Latest source date Jun 24, 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 24, 2026 FDA device enforcement ### [EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422](https://isitonrecall.com/recall/fda-device-z-2806-2026-eopa-elongated-one-piece-arterial-cannula-blunt-22fr-intended-for-use-with-cardiopulmonary-bypass-as/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypas...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2806-2026%22) Jun 24, 2026 FDA device enforcement ### [EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522](https://isitonrecall.com/recall/fda-device-z-2807-2026-eopa-elongated-one-piece-arterial-cannula-blunt-22fr-intended-for-use-with-cardiopulmonary-bypass-as/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypas...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2807-2026%22) Jun 24, 2026 FDA device enforcement ### [EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622](https://isitonrecall.com/recall/fda-device-z-2808-2026-eopa-elongated-one-piece-arterial-cannula-dil-tip-22fr-intended-for-use-with-cardiopulmonary-bypass/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2808-2026%22) Jun 24, 2026 FDA device enforcement ### [EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722](https://isitonrecall.com/recall/fda-device-z-2809-2026-eopa-elongated-one-piece-arterial-cannula-dil-tip-22fr-intended-for-use-with-cardiopulmonary-bypass/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary byp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2809-2026%22) Jun 24, 2026 FDA device enforcement ### [EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222](https://isitonrecall.com/recall/fda-device-z-2810-2026-eopa-3d-arterial-cannula-dil-tip-22fr-intended-for-use-with-cardiopulmonary-bypass-as-an-arterial-re/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arteria...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2810-2026%22) Jun 24, 2026 FDA device enforcement ### [EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322](https://isitonrecall.com/recall/fda-device-z-2811-2026-eopa-3d-arterial-cannula-22fr-intended-for-use-with-cardiopulmonary-bypass-as-an-arterial-return-can/) Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2811-2026%22) May 25, 2026 FDA device enforcement ### [Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula](https://isitonrecall.com/recall/fda-device-z-2738-2026-medtronic-dlp-one-piece-pediatric-arterial-cannula-product-number-cfn-77010-cardiopulmonary-bypass-v/) Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR. [Official source for Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary byp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2738-2026%22) May 25, 2026 FDA device enforcement ### [Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula](https://isitonrecall.com/recall/fda-device-z-2739-2026-medtronic-bio-medicus-adult-cannula-kit-product-number-cfn-96530-115-cardiopulmonary-bypass-vascular/) Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR. [Official source for Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vas...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2739-2026%22) May 12, 2026 FDA device enforcement ### [Octopus Evolution Tissue Stabilizer, Model TS2000](https://isitonrecall.com/recall/fda-device-z-2575-2026-octopus-evolution-tissue-stabilizer-model-ts2000/) During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended de... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Octopus Evolution Tissue Stabilizer, Model TS2000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2575-2026%22) May 12, 2026 FDA device enforcement ### [Octopus Evolution AS Tissue Stabilizer, Model TS2500](https://isitonrecall.com/recall/fda-device-z-2576-2026-octopus-evolution-as-tissue-stabilizer-model-ts2500/) During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended de... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Octopus Evolution AS Tissue Stabilizer, Model TS2500](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2576-2026%22) May 12, 2026 FDA device enforcement ### [Octopus 4 Tissue Stabilizer, Model 29400](https://isitonrecall.com/recall/fda-device-z-2577-2026-octopus-4-tissue-stabilizer-model-29400/) During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended de... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Octopus 4 Tissue Stabilizer, Model 29400](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2577-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2214-2026-medtronic-gundry-retrograde-cannula-manual-inflate-silicone-body-13fr-model-94113t-cardiopulmonary-b/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmon...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2214-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2215-2026-medtronic-gundry-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94115t-cardiopulmonary-b/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmon...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2215-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2216-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94215t-cardiopulmonary-bypa/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2216-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2217-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94665-cardiopulmonary-bypas/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2217-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2218-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94725-cardiopulmonary-bypas/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2218-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2219-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-13fr-model-94913-cardiopulmonary-bypas/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2219-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2220-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-13fr-model-94913l-cardiopulmonary-bypa/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2220-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2221-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94915-cardiopulmonary-bypas/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2221-2026%22) Apr 21, 2026 FDA device enforcement ### [Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter](https://isitonrecall.com/recall/fda-device-z-2222-2026-medtronic-dlp-retrograde-cannula-manual-inflate-silicone-body-15fr-model-94965-cardiopulmonary-bypas/) Certain lots of product have the potential for a sterile barrier breach. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungar... [Official source for Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2222-2026%22) ## Reasons in these listed records - Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. - Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. - During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. - Certain lots of product have the potential for a sterile barrier breach. These examples come from this result page and are not a ranking of every recall reason. ## Checking Medtronic Perfusion Systems ### Is there a recall on medtronic perfusion systems right now? This archive contains 56 records, including 56 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 Medtronic Perfusion Systems](https://isitonrecall.com/check/?q=Medtronic%20Perfusion%20Systems) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)