Medtronic Implantable Defibrillators Recall Due to Potential Therapy Failure
Medtronic 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. The recalled devices contain a specific feedthrough component.
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 designation establishes a minimum severity score of 4. Although no adverse events have been reported, the potential for reduced or absent defibrillator output in patients with these implanted devices poses serious risk.
Plain-English summary
Medtronic Inc. is recalling certain CRT-D DTBC2D4 BRAVA IS1/DF4 INTL implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These devices contain a specific glassed feedthrough component that may lead to a rare potential for reduced or no-energy output during high voltage therapy, typically delivered at 0-12 joules.
The recall affects approximately 3,355 units distributed in the United States and worldwide. The affected devices are identified by GTIN 00643169720305 and GTIN 00643169980136, with multiple lot serial numbers beginning with "BLZ."
Patients who have received one of these devices should contact their healthcare provider or cardiologist to determine whether they are affected and to discuss appropriate monitoring or management.
The recalled product
- Product
- CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
- Affected units
- 3,355
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 00643169720305
- Lot Serial Numbers: BLZ604044S
- BLZ604109S
- BLZ603698S
- BLZ603713S
- BLZ603726S
- BLZ603835S
- BLZ604013S
- BLZ604101S
- BLZ603725S
- BLZ604036S
- BLZ604059S
- BLZ603770S
- BLZ604032S
- BLZ603602S
- BLZ603626S
- BLZ604001S
- BLZ603743S
- BLZ604536S
- BLZ603622S
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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