Medtronic recalls specific implantable defibrillators due to rare risk of device malfunction. Affected units have serial numbers RSN600251S and RSN600656S. No immediate action required per recall.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Take action
Contact the company
📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic Cobalt DR MRI SureScan DDPB3D1 Defibrillator Recall: Rare Performance Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63912-medtronic-cobalt-dr-mri-surescan-ddpb3d1-defibrillator-recall-rare-performance. Based on FDA recall #Z-0928-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2021%22&limit=1).
The FDA announced on 2020-11-15 that Medtronic Inc. voluntarily recalled its Cobalt DR MRI SureScan DDPB3D1 implantable dual chamber cardioverter defibrillators due to potential loss of function, according to the FDA.
How to tell if you have it
Medtronic Cobalt DR MRI SureScan DDPB3D1
Serial Numbers: RSN600251S, RSN600656S
The hazard
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Context
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2017-12-19. Other recent recalls of similar products include Medtronic CRT-D Devices May Have Reduced Energy Output During Therapy (2023-05-10), Medtronic - Cardiac Rhythm and Heart Failure (CRHF) Devices (2022-06-22), Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots (2022-04-20), Medtronic Sphere-9 Catheter Recall: Risk of Ventricular Fibrillation with Biotronik ICDs (2026-03-11), Philips Brilliance CT 64 Medical Scanner Recall: Unintended Radiation Risk (2026-08-07) and Philips Allura Xper FD10C Medical System Recall: Risk of Electrical Short-Circuits (2025-12-15).
How to tell if you have this one
Check if your defibrillator has the model name 'Medtronic Cobalt DR MRI SureScan DDPB3D1' and serial numbers RSN600251S or RSN600656S. This model includes Bluetooth wireless telemetry.
Brand
Medtronic
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Distribution to US states of GA, PA, NJ, and France
Recall number
Product, codes & lots
Z-0926-2021
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR); Serial Numbers: RTK602501S, RTK602506S
Z-0927-2021
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR); Serial Numbers: RTP601047S, RTP601055S
Z-0928-2021
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR); Serial Numbers: RSN600251S, RSN600656S
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for the serial numbers RSN600251S or RSN600656S on your device.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of GA, PA, NJ, and France” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, New Jersey, Pennsylvania.
Recall timeline
FDA terminated this recall 5.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0928-2021 (November 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0928-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.