Medtronic Implantable Defibrillators Risk Failing to Deliver Electrical Therapy
Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing 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: This is classified as FDA Class I, which mandates a minimum severity rating of Severe. Although no illnesses or injuries have been reported, the potential for complete failure of critical therapy delivery in an implanted cardiac device represents a serious hazard.
Plain-English summary
Medtronic Inc. is recalling 404 units of the CRTD CROME HF QUAD MRI IS4 DF1 (Model DTPC2Q1) implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured with a specific feedthrough component.
A rare potential exists for reduced or no-energy output during high-voltage therapy (typically 0-12 joules) in these devices. The defect is related to the specific type of feedthrough used in manufacturing.
These devices have been distributed throughout the United States and worldwide. The FDA has classified this as a Class I recall, indicating a serious hazard.
The recalled product
- Product
- CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-output
- manufacturing-defect
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 00763000178260
- Lot Serial Numbers: RTT600077S
- RTT600166S
- RTT600169S
- RTT600064S
- RTT600083S
- RTT600071S
- RTT600042S
- RTT600028S
- RTT600107S
- RTT600034S
- RTT600421S
- RTT600432S
- RTT600434S
- RTT600574S
- RTT600161S
- RTT600054S
- RTT600160S
- RTT600231S
- RTT600431S
Distribution
Distributed nationwide across the United States.
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