Implantable cardiac defibrillators recalled for potential therapy failure risk
Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured 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: FDA classified this recall as Class I, which mandates a minimum severity of Severe per the rubric. Although no illnesses or injuries have been reported, the potential for reduced or no energy output in a life-critical cardiac device constitutes a serious malfunction risk that could prevent lifesaving therapy.
Plain-English summary
The ICD COBALT VR MRI DF4 implantable cardioverter defibrillators are being recalled due to a rare potential for reduced or no energy output during high-voltage therapy delivery. The defect is associated with a specific type of glassed feedthrough component used in the device.
High-voltage therapy is typically delivered at 0-12 joules. In affected devices, this therapy may not reach target energy levels or may fail to deliver entirely, potentially preventing the device from functioning as intended when therapy is needed.
This recall affects 7,048 units distributed nationally and worldwide. Medtronic and the FDA have identified the specific lot serial numbers associated with this issue.
Patients with affected devices should contact their healthcare provider or Medtronic immediately to determine if their device is part of this recall and discuss any necessary next steps, including potential device monitoring or replacement.
The recalled product
- Product
- ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- device-malfunction
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 00763000178512
- Lot Serial Numbers: RSF600012S
- RSF600254S
- RSF600591S
- RSF600655S
- RSF600822S
- RSF601247S
- RSF602653S
- RSF603908S
- RSF601102S
- RSF607914S
- RSF605967S
- RSF600633S
- RSF600649S
- RSF600867S
- RSF600868S
- RSF600869S
- RSF600872S
- RSF600873S
- RSF600874S
Distribution
Distributed nationwide across the United States.
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