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.
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: 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
- Affected units
- 15,427
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.
Part of a larger recall action
This product is one of 120 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 120 products in this recall →Related recalls
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