Implantable defibrillators may fail to deliver emergency therapy
Medtronic is recalling CRT-D defibrillators that may fail to deliver electrical therapy during life-threatening heart rhythms due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of an implantable device with potential therapy delivery failure. Per the rubric, FDA Class I recalls must score at least 4 (Severe). No deaths or reported injuries are documented.
Plain-English summary
Medtronic is recalling certain CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD implantable cardioverter defibrillators. The devices may experience reduced or no-energy output during high voltage therapy due to a specific glassed feedthrough component that may malfunction.
The affected devices have been distributed nationwide and worldwide. The recall involves devices with lot serial number BLF258300H.
Implantable cardioverter defibrillators are implanted to deliver electrical therapy to correct abnormal heart rhythms. The potential for device malfunction during therapy is classified as a Class I safety concern by the FDA.
The recalled product
- Product
- CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators
- Affected units
- 1
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 (2)
- GTIN 00643169956650
- Lot Serial Numbers: BLF258300H
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
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
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