Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic's implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a feedthrough defect. Approximately 6,821 devices are affected 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 classification requires a minimum severity of 4. While no illnesses or deaths are reported in the source, the defect affects critical life-sustaining devices essential for managing potentially fatal cardiac arrhythmias, carrying significant potential for serious patient harm.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DVBC3D1 EVERA S IS1/DF1. Certain units manufactured with a specific glassed feedthrough component have a rare potential for reduced or complete loss of energy output during high-voltage (HV) therapy delivery.
High-voltage therapy is typically delivered at energy levels of 0 to 12 joules. Approximately 6,821 affected units were distributed nationwide in the United States and internationally. The recalled devices are identified by specific lot serial numbers provided by the manufacturer.
Patients with implanted ICDs or CRT-Ds should contact their cardiologist or implanting institution to determine whether their device is affected by this recall and to discuss appropriate management or monitoring options.
The recalled product
- Product
- ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
- Affected units
- 6,821
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 00643169720473
- Lot Serial Numbers: BWM204909H
- BWM204998H
- BWM205011H
- BWM205017H
- BWM204963H
- BWM204962H
- BWM205000H
- BWM204927H
- BWM204911H
- BWM204921H
- BWM204926H
- BWM204932H
- BWM204936H
- BWM204944H
- BWM204954H
- BWM204955H
- BWM204959H
- BWM204983H
- BWM204984H
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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