--- title: "Abbott Medical Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Abbott Medical recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/abbott-medical/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Abbott Medical recall records **39** reported ongoing 39 records in this archive. Latest source date May 12, 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 May 12, 2026 FDA device enforcement ### [Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software](https://isitonrecall.com/recall/fda-device-z-2405-2026-merlin-patient-care-system-pcs-software-merlin-pcs-3650-programmer-model-3330-software/) Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH,... [Official source for Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2405-2026%22) Oct 6, 2025 FDA device enforcement ### [Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400](https://isitonrecall.com/recall/fda-device-z-0458-2026-eterna-scs-ipg-implantable-pulse-generator-model-number-32400/) There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0458-2026%22) Oct 6, 2025 FDA device enforcement ### [Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400](https://isitonrecall.com/recall/fda-device-z-0459-2026-liberta-rc-dbs-ipg-implantable-pulse-generator-model-number-62400/) There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0459-2026%22) Feb 15, 2025 FDA device enforcement ### [Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports ...](https://isitonrecall.com/recall/fda-device-z-1557-2025-aveir-dr-leadless-pacemaker-lp-ventricular-device-ref-lsp202v-udi-di-code-05415067040725-ref-lsp112v/) Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in... [Official source for Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF L...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1557-2025%22) Nov 21, 2024 FDA device enforcement ### [The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 softwar...](https://isitonrecall.com/recall/fda-device-z-0753-2025-the-merlin-pcs-3650-programmer-model-3330-the-merlin-pcs-programmer-model-3650-is-a-portable-dedicat/) Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window ( Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, N... [Official source for The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, ded...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0753-2025%22) Oct 17, 2024 FDA device enforcement ### [Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile](https://isitonrecall.com/recall/fda-device-z-0491-2025-abbott-navitor-titan-vision-technology-transcatheter-aortic-heart-valve-35-mm-nvro-35-sterile/) A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. Class II Reported ongoing Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. [Official source for Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0491-2025%22) Oct 17, 2024 FDA device enforcement ### [Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile](https://isitonrecall.com/recall/fda-device-z-0492-2025-abbott-navitor-transcatheter-aortic-heart-valve-29-mm-nvtr-29-sterile/) A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. Class II Reported ongoing Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. [Official source for Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0492-2025%22) Oct 17, 2024 FDA device enforcement ### [Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile](https://isitonrecall.com/recall/fda-device-z-0493-2025-abbot-navitor-vision-technology-transcatheter-aortic-heart-valve-29-mm-nvro-29-sterile/) A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. Class II Reported ongoing Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. [Official source for Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0493-2025%22) Oct 17, 2024 FDA device enforcement ### [Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile](https://isitonrecall.com/recall/fda-device-z-0494-2025-abbott-navitor-vision-technology-transcatheter-aortic-heart-valve-27-mm-nvro-27-sterile/) A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. Class II Reported ongoing Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. [Official source for Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0494-2025%22) Oct 17, 2024 FDA device enforcement ### [Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile](https://isitonrecall.com/recall/fda-device-z-0495-2025-abbott-navitor-transcatheter-aortic-heart-valve-27-mm-nvtr-27-sterile/) A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure. Class II Reported ongoing Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. [Official source for Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0495-2025%22) Oct 1, 2024 FDA device enforcement ### [Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care N...](https://isitonrecall.com/recall/fda-device-z-0551-2025-merlin-home-transmitter-ref-ex1100-the-merlin-home-m-h-transmitter-is-intended-to-transfer-stored-da/) Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. Class III Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA... [Official source for Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer sto...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0551-2025%22) Oct 1, 2024 FDA device enforcement ### [Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use....](https://isitonrecall.com/recall/fda-device-z-0552-2025-merlin-home-with-the-merlinondemand-capability-transmitter-ref-ex1150-merlin-home-with-the-merlinond/) Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. Class III Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA... [Official source for Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the Merlin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0552-2025%22) May 22, 2024 FDA device enforcement ### [Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2429-2024-abbott-infinity-5-implantable-pulse-generator-ref-6660-sterileeo-rx-only/) Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA,... [Official source for Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2429-2024%22) May 22, 2024 FDA device enforcement ### [Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2430-2024-abbott-infinity-5-implantable-pulse-generator-ref-6661-sterileeo-rx-only/) Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA,... [Official source for Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2430-2024%22) May 22, 2024 FDA device enforcement ### [Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2431-2024-abbott-infinity-7-implantable-pulse-generator-ref-6662-sterileeo-rx-only/) Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA,... [Official source for Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2431-2024%22) May 22, 2024 FDA device enforcement ### [Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2432-2024-abbott-infinity-7-implantable-pulse-generator-ref-6663-sterileeo-rx-only/) Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA,... [Official source for Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2432-2024%22) May 16, 2024 FDA device enforcement ### [Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY](https://isitonrecall.com/recall/fda-device-z-2265-2024-abbott-liberta-rc-implantable-pulse-generator-ref-62400-sterile-rxonly/) Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy. Class II Reported ongoing Distribution: US: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI,... [Official source for Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2265-2024%22) May 16, 2024 FDA device enforcement ### [Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2358-2024-abbott-proclaim-xr-5-implantable-pulse-generator-ref-3660-sterile-eo-rx-only/) The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA,... [Official source for Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2358-2024%22) May 16, 2024 FDA device enforcement ### [Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2359-2024-abbott-proclaim-5-implantable-pulse-generator-ref-3661-sterile-eo-rx-only/) The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA,... [Official source for Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2359-2024%22) May 16, 2024 FDA device enforcement ### [Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only](https://isitonrecall.com/recall/fda-device-z-2360-2024-abbott-proclaim-xr-7-implantable-pulse-generator-ref-3662-sterile-eo-rx-only/) The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA,... [Official source for Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2360-2024%22) ## Reasons in these listed records - Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. - There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with ... - Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. - Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window ( These examples come from this result page and are not a ranking of every recall reason. ## Checking Abbott Medical ### Is there a recall on abbott medical right now? This archive contains 39 records, including 39 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 Abbott Medical](https://isitonrecall.com/check/?q=Abbott%20Medical) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)