Implantable Cardioverter Defibrillators Risk Energy Output Failure
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.
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 Severe rating. Although no injuries or deaths are reported in the source, the potential for complete treatment failure in a critical implantable cardiac device justifies this severity level.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTBA2QQ VIVA QUAD XT, that were manufactured with a specific glassed feedthrough. The recall affects 2,931 units distributed nationwide and worldwide.
The recalled devices carry a rare potential for reduced or no-energy output during high voltage (HV) therapy, typically in the 0-12J energy range. This malfunction could prevent the device from delivering appropriate shock therapy when medically necessary.
Patients with affected devices should contact their healthcare provider or cardiologist to verify whether their device is included in this recall. Medtronic has identified specific lot serial numbers to facilitate identification.
The recalled product
- Product
- CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- reduced-energy-output
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 00643169720169
- Lot Serial Numbers: BLG624311S
- BLG624755S
- BLG625177S
- BLG625181S
- BLG625182S
- BLG625188S
- BLG625193S
- BLG625324S
- BLG625325S
- BLG625434S
- BLG625596S
- BLG625598S
- BLG625606S
- BLG625608S
- BLG625636S
- BLG625647S
- BLG625702S
- BLG625740S
- BLG625741S
Distribution
Distributed nationwide across the United States.
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