Implantable Cardiac Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.
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 applies to devices where there is reasonable probability of serious adverse health consequences. Although no illnesses or injuries have been reported to date, the device's critical life-saving function and potential for therapy failure during cardiac emergencies warrant the Class I designation and Severe severity rating.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, that were manufactured with specific glassed feedthrough components. The recall involves 7,921 units distributed nationwide in the United States and worldwide.
The affected devices may deliver reduced or no electrical energy output during high-voltage defibrillation therapy, which typically operates in the 0 to 12 joule range. This rare defect in the feedthrough component could prevent these life-saving devices from functioning properly during a critical cardiac emergency when the patient needs therapy most.
Patients with affected devices are identified by specific lot serial numbers listed in the recall notice. Healthcare providers and patients should contact Medtronic to determine whether their particular device is included in the recall based on the device's serial number and lot number.
The recalled product
- Product
- CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-failure
- energy-output-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 00643169720367
- Lot Serial Numbers: BLW607464S
- BLW607601S
- BLW607643S
- BLW607705S
- BLW607921S
- BLW608132S
- BLW608133S
- BLW608134S
- BLW608135S
- BLW608235S
- BLW608746S
- BLW609769S
- BLW606989S
- BLW607809S
- BLW607902S
- BLW607917S
- BLW607284S
- BLW607004S
- BLW607851S
Distribution
Distributed nationwide across the United States.
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