--- title: "St. Jude Medical, Cardiac Rhythm Management Division Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search St. Jude Medical, Cardiac Rhythm Management Division recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/st-jude-medical-cardiac-rhythm-management-division/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # St. Jude Medical, Cardiac Rhythm Management Division recall records **8** reported ongoing 8 records in this archive. Latest source date Jun 17, 2022. 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 17, 2022 FDA device enforcement ### [Merlin PCS 3650 programmer Model 3330 software](https://isitonrecall.com/recall/fda-device-z-1495-2022-merlin-pcs-3650-programmer-model-3330-software/) There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. Class II Reported ongoing Distribution: US: 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 NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: AL... [Official source for Merlin PCS 3650 programmer Model 3330 software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1495-2022%22) Jun 17, 2022 FDA device enforcement ### [Merlin 2 PCS MER37000 programmer Model MER3400 software](https://isitonrecall.com/recall/fda-device-z-1496-2022-merlin-2-pcs-mer37000-programmer-model-mer3400-software/) The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. Class II Reported ongoing Distribution: US: 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 NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: AL... [Official source for Merlin 2 PCS MER37000 programmer Model MER3400 software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1496-2022%22) Jun 17, 2022 FDA device enforcement ### [Merlin.net model MN5000 Software](https://isitonrecall.com/recall/fda-device-z-1497-2022-merlin-net-model-mn5000-software/) The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. Class II Reported ongoing Distribution: US: 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 NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: AL... [Official source for Merlin.net model MN5000 Software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1497-2022%22) Mar 10, 2022 FDA device enforcement ### [Merlin PCS 3650 programmer Model 3330 software](https://isitonrecall.com/recall/fda-device-z-0964-2022-merlin-pcs-3650-programmer-model-3330-software/) Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute th... Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE... [Official source for Merlin PCS 3650 programmer Model 3330 software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0964-2022%22) Mar 10, 2022 FDA device enforcement ### [Merlin 2 PCS MER3700 programmer Model MER3400 software](https://isitonrecall.com/recall/fda-device-z-0965-2022-merlin-2-pcs-mer3700-programmer-model-mer3400-software/) Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute th... Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE... [Official source for Merlin 2 PCS MER3700 programmer Model MER3400 software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0965-2022%22) Mar 10, 2022 FDA device enforcement ### [Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q](https://isitonrecall.com/recall/fda-device-z-0988-2022-gallant-dr-implantable-cardioverter-defibrillator-ref-cddra500q/) Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these device... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. [Official source for Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0988-2022%22) Mar 10, 2022 FDA device enforcement ### [Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q](https://isitonrecall.com/recall/fda-device-z-0989-2022-gallant-vr-implantable-cardioverter-defibrillator-ref-cdvra500q/) Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these device... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. [Official source for Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0989-2022%22) Mar 10, 2022 FDA device enforcement ### [Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q](https://isitonrecall.com/recall/fda-device-z-0990-2022-gallant-hf-implantable-cardioverter-defibrillator-ref-cdhfa500q/) Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these device... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. [Official source for Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0990-2022%22) ## Reasons in these listed records - There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. - The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. - Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test ins... - Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in re... These examples come from this result page and are not a ranking of every recall reason. ## Checking St. Jude Medical, Cardiac Rhythm Management Division ### Is there a recall on st. jude medical, cardiac rhythm management division right now? This archive contains 8 records, including 8 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 St. Jude Medical, Cardiac Rhythm Management Division](https://isitonrecall.com/check/?q=St.%20Jude%20Medical%2C%20Cardiac%20Rhythm%20Management%20Division) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)