Lower riskMedical device recall · FDA · Published December 7, 2023
Medtronic Cobalt XT DR MRI Defibrillator Recall: Battery Retesting Risk
Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with product number DDPA2D1 due to potential battery retesting during quality checks, which may affect safety.
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
Take action
Contact the company
📍Recalling firmMedtronic Inc.8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic Cobalt XT DR MRI Defibrillator Recall: Battery Retesting Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56604-medtronic-cobalt-xt-dr-mri-defibrillator-recall-battery-retesting-risk. Based on FDA recall #Z-0779-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0779-2024%22&limit=1).
The FDA announced on 2023-12-07 that Medtronic Inc. is voluntarily recalling one Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1, due to potential battery testing errors. The device was distributed in Florida.
How to tell if you have it
Brand: Medtronic
Product: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator
Product Number: DDPA2D1
UDI/DI: 00763000178338
Serial Number: RSL604096S
Quantity: 1 device
Distribution: Florida
The hazard
According to the FDA, internal review of Polaris battery assembly data revealed that some batteries underwent the High Potential test twice because the test screen did not prevent retesting after a failure. Some of these batteries were retested and passed.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Other recent recalls include the 2026-03-11 Medtronic Sphere-9 Catheter Recall for risk of ventricular fibrillation, the 2025-12-04 Medtronic Abre Venous Stent Recall for potential stent migration, and the 2025-10-29 Medtronic EVX 60 Series recall for potential delayed high-voltage therapy. Other recent recalls of similar products include the 2025-10-16 Canon Vantage Galan 3T Medical Device Recall for electrode distance risk, the 2026-05-13 Thoratec HeartMate 3 LVAS Kits Recall for 11 volt battery failures risk, and the 2026-05-13 HeartMate 11V Backup Battery Recall for battery failures risk.
How to tell if you have this one
Check for product number DDPA2D1 on the device label. The specific serial number RSL604096S indicates the recalled units.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for product number DDPA2D1 and serial number RSL604096S on the device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall is due to potential battery retesting during quality checks, but the device itself is not considered dangerous. Medtronic states this is a low-risk issue.
What should I do if I have this defibrillator?
The recall does not require immediate action. Check the device label for the product number and serial number to confirm if it's affected.
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-0779-2024 (December 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0779-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.