Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.
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: This is an FDA Class I recall without reported deaths, serious injuries, or hospitalizations. FDA Class I classification indicates a serious potential for device failure. The hazard affects critical cardiac therapy delivery, warranting a Severe rating.
Plain-English summary
Medtronic Inc. is recalling the CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD implantable cardioverter defibrillator (Model DTBA2D1G). Eight units manufactured with a specific feedthrough component are identified as affected.
These devices carry a rare potential for reduced or no energy output during high voltage therapy (typically 0-12 joules). The defect is associated with a specific feedthrough design in the manufacturing process.
The affected devices were distributed nationwide and worldwide. Eight lot serial numbers are identified in this Class I recall: BLJ622587S, BLJ622075S, BLJ622585S, BLJ623836S, BLJ622076S, BLJ623838S, BLJ622586S, and BLJ623837S.
The recalled product
- Product
- CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
- Affected units
- 8
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 (9)
- GTIN 00763000071431
- Lot Serial Numbers: BLJ622587S
- BLJ622075S
- BLJ622585S
- BLJ623836S
- BLJ622076S
- BLJ623838S
- BLJ622586S
- BLJ623837S
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
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