Agency classClass IOur severity:Severe FDA (Devices)·Z-1487-2022·Announced 2022-08-17

Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy

Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.

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, establishing a minimum severity of 4 per the rubric. The hazard—reduced shock energy delivery—affects the device's core function to provide critical defibrillation therapy. While no deaths or injuries have been reported, the failure could prevent proper treatment of life-threatening cardiac arrhythmias.

Plain-English summary

Medtronic is recalling 2,866 Cobalt implantable cardioverter defibrillators (ICDs and CRT-Ds) worldwide due to a potential defect affecting high-voltage shock energy delivery. During therapy, affected devices may deliver approximately 79% of their programmed energy level, which could reduce treatment effectiveness.

The defect impacts Cobalt VR ICD models DVPB3D1 and DVPB3D4, and Cobalt DR ICD models DDPB3D1 and DDPB3D4, with specific serial numbers identified by Medtronic. The recall is designated FDA Class I.

Patients with affected devices should contact their healthcare provider or Medtronic directly for guidance. A software update or device replacement may be necessary. Healthcare providers can verify device serial numbers against the recall list provided by Medtronic.

The recalled product

Product: Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Cardiac Implantable Defibrillator
Hazard: reduced-shock-energy
therapy-failure
defibrillation-failure
Affected units: 2,866

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)

a. Model Numbers: DVPB3D1: GTIN 00763000178499
Serial Numbers: RSE600212S
RSE600229S
RSE600406S
RSE600450S
RSE600505S
RSE600518S
RSE600519S
RSE600520S
RSE600538S
RSE600539S
RSE600621S
RSE600676S
RSE600681S
RSE600709S
RSE600715S
RSE600716S
RSE600717S
RSE600718S
RSE600725S

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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

See all →

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Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
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Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
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Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · reduced shock energy