Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although classified as FDA Class I (indicating potential serious harm), the source describes only a 'rare potential' for the hazard with no reported illnesses or injuries. Per the rubric, theoretical hazards without reported incidents are capped at High severity despite the Class I designation.
Plain-English summary
Medtronic Inc. is recalling specific lots of its CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US implantable cardioverter defibrillators (ICDs and CRT-Ds). These devices were manufactured with a specific glassed feedthrough component.
There is a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12J) in affected devices. This defect could prevent the device from delivering critical therapy when needed.
The recall applies to implantable defibrillators distributed nationwide and worldwide. Affected devices are identified by specific lot serial numbers provided in the FDA recall notice.
Patients implanted with potentially affected devices should contact their healthcare provider or Medtronic to determine whether their device is included in the recall.
The recalled product
- Product
- CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- therapy-delivery-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 00643169720206
- Lot Serial Numbers: BLM202912H
- BLM203000H
- BLM202895H
- BLM202965H
- BLM203007H
- BLM203028H
- BLM203031H
- BLM203063H
- BLM202844H
- BLM202900H
- BLM203042H
- BLM203014H
- BLM203015H
- BLM203062H
- BLM202811H
- BLM202838H
- BLM202857H
- BLM202858H
- BLM202881H
Distribution
Distributed nationwide across the United States.
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