Implantable Cardioverter Defibrillators Recalled Due to Potential Therapy Failure
Medtronic is recalling approximately 15,427 implantable cardioverter defibrillators with a specific feedthrough due to a rare potential for reduced or no energy output during high voltage therapy. Patients should contact their healthcare provider.
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 Class I classification mandates a minimum severity of Severe. Although no illnesses or injuries have been reported, the potential for reduced or no-energy output during therapy in an implanted life-critical device justifies this classification.
Plain-English summary
The CRTD COBALT HF QUAD MRI IS4 DF4 (Model DTPB2QQ) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators are subject to recall due to a rare potential for reduced or no-energy output during high voltage therapy. This hazard affects devices manufactured with a specific glassed feedthrough.
Approximately 15,427 units have been distributed both within the United States and worldwide. The recall applies to currently available inventory as well as devices previously implanted in patients.
Patients with implanted devices from this recall should contact their healthcare provider to determine whether their device is affected and discuss appropriate next steps for care.
The recalled product
- Product
- CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-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)
- GTIN 00763000178178
- Lot Serial numbers: RTK605097S
- RTK600114S
- RTK600141S
- RTK600852S
- RTK600858S
- RTK601106S
- RTK601201S
- RTK602089S
- RTK602953S
- RTK603591S
- RTK604031S
- RTK600525S
- RTK602527S
- RTK606714S
- RTK608837S
- RTK608930S
- RTK610777S
- RTK600938S
- RTK600939S
Distribution
Distributed nationwide across the United States.
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