ICD Cobalt VR MRI Implantable Defibrillators Recall Due to Potential Therapy Failure
Medtronic is recalling 1,930 ICD Cobalt VR MRI implantable defibrillators due to a rare risk of reduced or no-energy output during high voltage therapy. The defect affects units with a specific glassed feedthrough component.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. While the source does not report deaths or serious injuries, the defect affects implantable devices critical to cardiac function, and the potential for reduced or no-energy output during defibrillation therapy represents a significant risk of harm to patients dependent on these devices.
Plain-English summary
Medtronic Inc. is recalling 1,930 units of the ICD Cobalt VR MRI IS1 DF1 implantable cardioverter defibrillators due to a rare potential for reduced or no-energy output during high voltage (HV) therapy, typically 0-12 joules.
The issue is associated with implantable devices manufactured with a specific glassed feedthrough component. This defect could affect the device's ability to deliver the correct energy output during defibrillation therapy.
The recall affects 1,930 units distributed nationwide and worldwide. Multiple lot serial numbers are included across two GTINs: 00763000178499 and 00763000178505.
Patients with an affected implantable cardioverter defibrillator should contact their physician immediately to determine if their device is involved in this recall. Medtronic is working with healthcare providers to address affected units.
The recalled product
- Product
- ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- high-voltage-therapy-failure
- reduced-energy-output
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 (20)
- GTIN 00763000178499
- Lot Serial Numbers: RSE600116S
- RSE600346S
- RSE600428S
- RSE600572S
- RSE600505S
- RSE600512S
- RSE600513S
- RSE600515S
- RSE600517S
- RSE600518S
- RSE600519S
- RSE600520S
- RSE601603S
- RSE601609S
- RSE601846S
- RSE601849S
- RSE601856S
- RSE601872S
- RSE601873S
Distribution
Distributed nationwide across the United States.
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