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.
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, 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
- 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 →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
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- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
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Same hazard · reduced shock energy
See all →- SevereCobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- SevereCrome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereCobalt Implantable Defibrillators May Deliver Reduced Shock Energy
FDA (Devices) · 2022-08-17