Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect
Medtronic is recalling eight COBALT XT VR MRI SureScan implantable cardioverter defibrillators due to weld cracks that caused device failure during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing defect (weld crack) in a high-risk implantable cardiac device. While no illnesses or injuries have been reported and the defect was identified during manufacturing before patient use, the potential for device failure in a life-critical device warrants a High severity rating.
Plain-English summary
Medtronic Inc. is recalling eight units of the COBALT XT VR MRI SureScan implantable cardioverter defibrillator (Model DVPA2D1) due to a manufacturing defect involving weld cracks.
The defect caused the affected devices to fail leak-check testing during manufacturing, indicating potential structural integrity issues. The specific serial numbers involved are: RSC604641S, RSC604642S, RSC604643S, RSC604644S, RSC604647S, RSC604653S, RSC604654S, and RSC604655S.
The recalled devices were distributed worldwide, including in the United States (California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia) and in multiple other countries.
Patients or healthcare providers with questions about this recall should contact Medtronic or their physician.
The recalled product
- Product
- COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- GTIN: 00763000711344
- Serial Numbers: RSC604641S
- RSC604642S
- RSC604643S
- RSC604644S
- RSC604647S
- RSC604653S
- RSC604654S
- RSC604655S.
Distribution
Part of a larger recall action
This product is one of 23 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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