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
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.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
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- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · energy output failure
See all →- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators risk energy output failure during high voltage therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Recalled for Rare Risk of Energy Output Failure
FDA (Devices) · 2023-06-28