Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification mandates a Critical severity score. This defect poses a direct threat to therapy delivery in implantable cardioverter defibrillators, which are lifesaving devices.
Plain-English summary
Medtronic Inc. is recalling specific implantable cardioverter defibrillators (CRT-D), Model DTBB1D4 VIVA S IS1/DF4 US. The devices may deliver reduced or no electrical energy during high-voltage therapy (typically 0-12 joules) due to a manufacturing defect in the feedthrough component. This is a Class I recall issued by the FDA.
The recall affects 182 units distributed nationwide and worldwide. The affected devices are identified by specific lot serial numbers listed in the FDA recall documentation. Patients with affected devices and their healthcare providers should consult the FDA recall notice.
The specific manufacturing defect involves a glassed feedthrough component that can impair the device's ability to deliver therapy. While the risk is described as rare, the potential failure of a lifesaving therapy device during treatment represents a serious patient safety concern.
The recalled product
- Product
- CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- therapy-delivery-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 00643169720268
- Lot Serial Numbers: BLN205385H
- BLN205423H
- BLN205617H
- BLN205500H
- BLN205517H
- BLN205644H
- BLN205573H
- BLN205101H
- BLN205395H
- BLN205424H
- BLN205448H
- BLN205505H
- BLN205574H
- BLN205579H
- BLN205432H
- BLN205460H
- BLN205545H
- BLN205566H
- BLN205554H
Distribution
Distributed nationwide across the United States.
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