Implantable Defibrillators May Fail to Deliver Therapy During Critical Events
Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide 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 for this life-critical cardiac implant device mandates a minimum severity rating of 4. While no deaths or illnesses have been reported and the defect is described as rare, failure to deliver therapy during a critical cardiac event could be fatal.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTBB2QQ VIVA QUAD S IS4/DF4 INTL. These are devices implanted to monitor heart rhythm and deliver electrical therapy for abnormal heartbeats.
The recalled devices may have a rare manufacturing defect in a specific feedthrough component. This defect can cause reduced or no energy output during high-voltage therapy (typically 0-12 joules). If this malfunction occurs when the device is needed to treat an abnormal heart rhythm, the necessary therapy may not be delivered.
A total of 523 units have been distributed in the US and worldwide. Patients with one of the affected lot serial numbers should contact their implanting physician or Medtronic immediately to verify whether their device is affected and to discuss what action should be taken.
The recalled product
- Product
- CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-delivery-failure
- 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 (20)
- GTIN 00643169720176
- Lot Serial Numbers: BLP603514S
- BLP603579S
- BLP603583S
- BLP603637S
- BLP603643S
- BLP603554S
- BLP603588S
- BLP603580S
- BLP603582S
- BLP603584S
- BLP603585S
- BLP603586S
- BLP603591S
- BLP603531S
- BLP603552S
- BLP603511S
- BLP603647S
- BLP603581S
- BLP603545S
Distribution
Distributed nationwide across the United States.
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