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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-shock-energy
- therapy-failure
- defibrillation-failure
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.
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