--- title: "Medtronic Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Medtronic Inc 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-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Medtronic Inc recall records **44** reported ongoing 45 records in this archive. Latest source date Mar 11, 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 Mar 11, 2026 FDA device enforcement ### [Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.](https://isitonrecall.com/recall/fda-device-z-1948-2026-medtronic-sphere-9-catheter-model-number-afr-00001-catheter-percutaneous-cardiac-ablation-for-treatm/) Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D)... Class II Reported ongoing Distribution: Worldwide [Official source for Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, fo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1948-2026%22) Dec 4, 2025 FDA device enforcement ### [Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G1...](https://isitonrecall.com/recall/fda-device-z-1098-2026-abre-venous-self-expanding-stent-system-model-numbers-ab9g14120090-ab9g12100090-ab9g14080090-ab9g120/) Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. Class II Reported ongoing Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebano... [Official source for Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1098-2026%22) Oct 29, 2025 FDA device enforcement ### [Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4](https://isitonrecall.com/recall/fda-device-z-0726-2026-aurora-ev-icd-and-clinical-ev-icd-single-chamber-extravascular-implantable-cardioverter-defibrillato/) There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibri...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0726-2026%22) Jun 18, 2025 FDA device enforcement ### [Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria ...](https://isitonrecall.com/recall/fda-device-z-2168-2025-medtronic-carelink-smartsync-patient-connector-model-number-24967-with-the-following-software-compon/) In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software co...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2168-2025%22) Jun 18, 2025 FDA device enforcement ### [Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Am...](https://isitonrecall.com/recall/fda-device-z-2169-2025-medtronic-carelink-smartsync-device-manager-model-number-24967a-with-the-following-software-componen/) In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software comp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2169-2025%22) Jun 17, 2025 FDA device enforcement ### [Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number ...](https://isitonrecall.com/recall/fda-device-z-2127-2025-medtronic-smartlink-software-loaded-on-smartsync-patient-connector-model-number-24967-with-the-follo/) A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous m... Class II Reported ongoing Distribution: Worldwide [Official source for Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2127-2025%22) Jun 17, 2025 FDA device enforcement ### [Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model ...](https://isitonrecall.com/recall/fda-device-z-2128-2025-medtronic-smartlink-software-loaded-on-carelink-smartsync-device-manager-model-number-24967a-with-th/) A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous m... Class II Reported ongoing Distribution: Worldwide [Official source for Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A wit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2128-2025%22) Apr 29, 2025 FDA device enforcement ### [Azure S DR MRI SureScan, Product number W3DR01](https://isitonrecall.com/recall/fda-device-z-1924-2025-azure-s-dr-mri-surescan-product-number-w3dr01/) Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or s... Class II Reported ongoing Distribution: International distribution of the country of UK. No US distribution. [Official source for Azure S DR MRI SureScan, Product number W3DR01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1924-2025%22) Jul 11, 2024 FDA device enforcement ### [2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PO...](https://isitonrecall.com/recall/fda-device-z-3152-2024-2090-programmers-with-serial-number-prefixes-pkk0-and-pkk1-a-2090-product-description-prgm-2090-prog/) Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher. Class II Reported ongoing Distribution: Worldwide distribution. [Official source for 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 20...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3152-2024%22) Apr 16, 2024 FDA device enforcement ### [COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2190-2024-cobalt-hf-quad-crt-d-mri-surescan-model-number-dtpb2qq-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2190-2024%22) Apr 16, 2024 FDA device enforcement ### [COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2191-2024-cobalt-xt-hf-crt-d-mri-surescan-model-number-dtpa2d1-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2191-2024%22) Apr 16, 2024 FDA device enforcement ### [Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2192-2024-cobalt-xt-hf-cdt-d-mri-surescan-model-number-dtpa2d4-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2192-2024%22) Apr 16, 2024 FDA device enforcement ### [COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2193-2024-cobalt-xt-hf-quad-crt-d-mri-surescan-model-number-dtpa2q1-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2193-2024%22) Apr 16, 2024 FDA device enforcement ### [COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2194-2024-cobalt-xt-hf-quad-crt-d-mri-surescan-model-number-dtpa2qq-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2194-2024%22) Apr 16, 2024 FDA device enforcement ### [CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2195-2024-crome-hf-quad-crt-d-mri-surescan-model-number-dtpc2qq-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2195-2024%22) Apr 16, 2024 FDA device enforcement ### [EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2196-2024-evera-s-vr-model-number-dvbc3d1-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2196-2024%22) Apr 16, 2024 FDA device enforcement ### [EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2197-2024-evera-mri-s-vr-surescan-model-number-dvmc3d4-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2197-2024%22) Apr 16, 2024 FDA device enforcement ### [EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2198-2024-evera-mri-s-dr-surescan-model-number-ddmc3d1-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2198-2024%22) Apr 16, 2024 FDA device enforcement ### [EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2199-2024-evera-mri-s-dr-surescan-model-number-ddmc3d4-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2199-2024%22) Apr 16, 2024 FDA device enforcement ### [PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator](https://isitonrecall.com/recall/fda-device-z-2200-2024-primo-mri-dr-surescan-model-number-ddmd3d1-implantable-cardioverter-defibrillator/) Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ... [Official source for PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2200-2024%22) ## Reasons in these listed records - Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The obse... - Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. - There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. - In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery. These examples come from this result page and are not a ranking of every recall reason. ## Checking Medtronic Inc ### Is there a recall on medtronic inc right now? This archive contains 45 records, including 44 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 Inc](https://isitonrecall.com/check/?q=Medtronic%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)