Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected 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: The FDA has classified this as a Class I recall, the agency's most serious classification for medical devices, indicating a potential for serious patient harm. Although no illnesses or deaths have been reported, the hazard affects the critical therapeutic function of life-saving implantable devices.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically model DTBB2D1 VIVA S IS1/DF1 INTL. These devices were manufactured with a specific glassed feedthrough component that poses a safety risk. A total of 1,076 units have been identified as affected and distributed in the United States and internationally.
The devices carry a rare potential for reduced or no energy output during high voltage therapy, typically at energy levels of 0 to 12 joules. This defect could prevent the affected devices from delivering adequate therapy when needed.
The recall affects specific lot serial numbers of the devices. Patients and healthcare providers should identify affected units using the lot numbers and serial numbers provided in the official recall notice. The affected devices are being recalled due to this manufacturing defect related to the feedthrough component.
The recalled product
- Product
- CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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 00643169720350
- Lot Serial Numbers: BLS604430S
- BLS604248S
- BLS604229S
- BLS604258S
- BLS604234S
- BLS604223S
- BLS604309S
- BLS604224S
- BLS604227S
- BLS604222S
- BLS604308S
- BLS604256S
- BLS604257S
- BLS604310S
- BLS604313S
- BLS604245S
- BLS604253S
- BLS604252S
- BLS604239S
Distribution
Distributed nationwide across the United States.
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