Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.
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 designation requires minimum severity of 4 (Severe). The defect affects a life-critical implantable cardiac device where failure to deliver therapy could have serious health consequences, though no illnesses or injuries have been reported in the source material.
Plain-English summary
Medtronic Inc. is recalling 14 units of the CRTD VIVA QUAD XT CUST PARY GOLD implantable cardioverter defibrillators (Model DTBA1QQPG). These are life-sustaining devices implanted in cardiac patients to regulate abnormal heart rhythms and deliver therapy when needed.
The recall is due to a rare potential for reduced or no energy output during high voltage (HV) therapy (typically 0-12 joules) in devices manufactured with a specific glassed feedthrough. This defect could impair the device's ability to deliver therapy when required.
The affected devices have US nationwide and worldwide distribution. Affected lot serial numbers are: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, and BLC229010H.
The recalled product
- Product
- CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- 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 (15)
- GTIN 00643169968585
- Lot Serial Numbers: BLC229283H
- BLC229226H
- BLC229270H
- BLC229280H
- BLC229229H
- BLC228997H
- BLC229238H
- BLC229043H
- BLC229231H
- BLC229046H
- BLC229045H
- BLC229230H
- BLC228995H
- BLC229010H
Distribution
Distributed nationwide across the United States.
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