Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.
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 medical device recall. The devices are critical for preventing sudden cardiac death, and potential failure to deliver therapy could result in serious injury or death. Rule: FDA Class I classifications require a minimum severity of 4.
Plain-English summary
Medtronic is recalling a specific model of implantable cardioverter-defibrillator (CRT-D) device. The CRT-D DTBB2Q1 VIVA QUAD S is designed to monitor heart rhythm and deliver electrical therapy to correct dangerous arrhythmias.
Affected devices may experience reduced or completely absent energy output during high-voltage therapy (typically 0-12 joules). This defect is caused by a specific type of feedthrough component used in manufacturing. The recall affects 7 units distributed nationwide and internationally.
Patients with affected devices should contact their healthcare provider or Medtronic directly for guidance. Patients should not discontinue use of their device, as it may still provide essential protection. Medical professionals should verify device serial numbers against the recall notice to determine if their patients' devices are affected.
The recalled product
- Product
- CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-delivery-failure
- reduced-energy-output
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 (8)
- GTIN 00643169980181
- Lot Serial Numbers: BLQ600039S
- BLQ600033S
- BLQ600034S
- BLQ600035S
- BLQ600036S
- BLQ600037S
- BLQ600038S
Distribution
Distributed nationwide across the United States.
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