Medtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
Medtronic has recalled 891 implantable cardioverter defibrillators (CRT-D) worldwide due to a rare potential for reduced or absent energy output during defibrillation therapy. Units manufactured with a specific feedthrough component are affected.
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 severity level of 4 per the recall rubric. No reported deaths or serious injuries are documented in the source material.
Plain-English summary
Medtronic Inc. is recalling CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 implantable cardioverter defibrillators and ICDs due to a rare potential for reduced or no-energy output during high voltage therapy (typically 0-12J). The recall affects 891 units distributed in the US and worldwide.
These defibrillators use a specific (glassed) feedthrough component that may cause the device to fail to deliver full therapeutic energy when needed. This defect could result in incomplete or absent defibrillation therapy during a cardiac emergency.
Patients with affected devices should contact Medtronic and their healthcare provider immediately for instructions on device management or replacement. The specific affected lot serial numbers are listed in the recall notice. Healthcare providers should review the recall details and discuss options with affected patients.
The recalled product
- Product
- CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- defibrillation-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 00643169720138
- Lot Serial Numbers: BLC228471H
- BLC228476H
- BLC228533H
- BLC228541H
- BLC228635H
- BLC228702H
- BLC228745H
- BLC228827H
- BLC228830H
- BLC228840H
- BLC228872H
- BLC227820H
- BLC228658H
- BLC228889H
- BLC228890H
- BLC228895H
- BLC228896H
- BLC228900H
- BLC228350H
Distribution
Distributed nationwide across the United States.
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