Implantable defibrillators may fail to deliver emergency therapy
Medtronic is recalling CRT-D defibrillators that may fail to deliver electrical therapy during life-threatening heart rhythms due to a defective feedthrough component. Affected devices were distributed nationwide and 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: FDA Class I recall of an implantable device with potential therapy delivery failure. Per the rubric, FDA Class I recalls must score at least 4 (Severe). No deaths or reported injuries are documented.
Plain-English summary
Medtronic is recalling certain CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD implantable cardioverter defibrillators. The devices may experience reduced or no-energy output during high voltage therapy due to a specific glassed feedthrough component that may malfunction.
The affected devices have been distributed nationwide and worldwide. The recall involves devices with lot serial number BLF258300H.
Implantable cardioverter defibrillators are implanted to deliver electrical therapy to correct abnormal heart rhythms. The potential for device malfunction during therapy is classified as a Class I safety concern by the FDA.
The recalled product
- Product
- CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; 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 (2)
- GTIN 00643169956650
- Lot Serial Numbers: BLF258300H
Distribution
Distributed nationwide across the United States.
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