Agency classClass IOur severity:Severe FDA (Devices)·Z-1820-2023·Announced 2023-06-28

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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)
Category: Medical Device — Implantable Defibrillators / Cardiac
Hazard: device-malfunction
high-voltage-therapy-failure
reduced-energy-output
Affected units: 1,930

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.

Part of a larger recall action

This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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.

See all 120 products in this recall →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

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Same hazard · device malfunction