Medtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
Medtronic has recalled 891 implantable cardioverter defibrillators (CRT-D) worldwide due to a rare potential for reduced or absent energy output during defibrillation therapy. Units manufactured with a specific feedthrough component 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 mandates a minimum severity level of 4 per the recall rubric. No reported deaths or serious injuries are documented in the source material.
Plain-English summary
Medtronic Inc. is recalling CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 implantable cardioverter defibrillators and ICDs due to a rare potential for reduced or no-energy output during high voltage therapy (typically 0-12J). The recall affects 891 units distributed in the US and worldwide.
These defibrillators use a specific (glassed) feedthrough component that may cause the device to fail to deliver full therapeutic energy when needed. This defect could result in incomplete or absent defibrillation therapy during a cardiac emergency.
Patients with affected devices should contact Medtronic and their healthcare provider immediately for instructions on device management or replacement. The specific affected lot serial numbers are listed in the recall notice. Healthcare providers should review the recall details and discuss options with affected patients.
The recalled product
- Product
- CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
- Affected units
- 891
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 00643169720138
- Lot Serial Numbers: BLC228471H
- BLC228476H
- BLC228533H
- BLC228541H
- BLC228635H
- BLC228702H
- BLC228745H
- BLC228827H
- BLC228830H
- BLC228840H
- BLC228872H
- BLC227820H
- BLC228658H
- BLC228889H
- BLC228890H
- BLC228895H
- BLC228896H
- BLC228900H
- BLC228350H
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)
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Same hazard · energy output failure
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
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- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
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- SevereImplantable defibrillators risk energy output failure during high voltage therapy
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FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
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