Implantable defibrillators risk energy output failure during high voltage therapy
Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.
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 classification mandates a minimum severity score of 4. The potential for reduced or no energy output during therapy in an implantable defibrillator constitutes a serious health risk that could prevent treatment of life-threatening cardiac arrhythmias.
Plain-English summary
Medtronic is recalling certain CRT-D VIVA XT implantable defibrillators due to a rare potential for reduced or no energy output during high voltage therapy, typically at energy levels of 0-12 joules. The issue affects devices manufactured with a specific feedthrough type and has been identified in currently available models distributed nationwide and worldwide.
The recalled devices may fail to deliver adequate electrical energy during defibrillation therapy, which could prevent the device from properly treating life-threatening cardiac arrhythmias. This defect applies to devices already implanted and currently in use in patients.
Patients with potentially affected devices should contact their healthcare provider or Medtronic for information about their specific device model and any necessary actions. Patients should work with their medical team to determine if their device is part of this recall and to discuss appropriate management options.
The recalled product
- Product
- CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
- Category
- Medical Device — Cardiac Implant
- Affected units
- 4,354
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 00643169217959
- Lot Serial Numbers: BLJ622286S
- BLJ622571S
- BLJ622623S
- BLJ622733S
- BLJ622742S
- BLJ622966S
- BLJ624144S
- BLJ622126S
- BLJ624009S
- BLJ622569S
- BLJ623322S
- BLJ622064S
- BLJ622092S
- BLJ623468S
- BLJ623621S
- BLJ623849S
- BLJ624135S
- BLJ622023S
- BLJ623580S
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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