Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification mandates a Critical severity score. This defect poses a direct threat to therapy delivery in implantable cardioverter defibrillators, which are lifesaving devices.
Plain-English summary
Medtronic Inc. is recalling specific implantable cardioverter defibrillators (CRT-D), Model DTBB1D4 VIVA S IS1/DF4 US. The devices may deliver reduced or no electrical energy during high-voltage therapy (typically 0-12 joules) due to a manufacturing defect in the feedthrough component. This is a Class I recall issued by the FDA.
The recall affects 182 units distributed nationwide and worldwide. The affected devices are identified by specific lot serial numbers listed in the FDA recall documentation. Patients with affected devices and their healthcare providers should consult the FDA recall notice.
The specific manufacturing defect involves a glassed feedthrough component that can impair the device's ability to deliver therapy. While the risk is described as rare, the potential failure of a lifesaving therapy device during treatment represents a serious patient safety concern.
The recalled product
- Product
- CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
- Affected units
- 182
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 00643169720268
- Lot Serial Numbers: BLN205385H
- BLN205423H
- BLN205617H
- BLN205500H
- BLN205517H
- BLN205644H
- BLN205573H
- BLN205101H
- BLN205395H
- BLN205424H
- BLN205448H
- BLN205505H
- BLN205574H
- BLN205579H
- BLN205432H
- BLN205460H
- BLN205545H
- BLN205566H
- BLN205554H
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 →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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
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