Implantable cardioverter defibrillators may fail to deliver therapy
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with specific glassed feedthroughs that may deliver 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: FDA Class I recall. The device malfunction affects a life-critical function (high voltage therapy delivery for potentially fatal arrhythmias), warranting the Severe classification despite no reported illnesses or deaths to date.
Plain-English summary
Medtronic is recalling certain Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) Model DVMB2D1. Approximately 2,310 units are affected, distributed nationwide and worldwide. The devices manufactured with a specific glassed feedthrough component are subject to this recall.
These devices carry a rare potential for reduced or no energy output during high voltage (HV) therapy, typically delivered at 0-12 joules. This malfunction could prevent the device from delivering the therapeutic shock needed to restore normal heart rhythm during dangerous arrhythmias, creating a serious risk to patient safety.
Patients with these devices should contact their healthcare provider to determine if their device is affected and to discuss appropriate management. Do not discontinue use of your device without consulting your physician, as the device continues to provide cardiac monitoring and therapy in most situations.
The recalled product
- Product
- ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
- Category
- Medical Device — Cardiac Implant
- Affected units
- 2,310
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 00643169837768
- Lot Serial Numbers: CWE602084S
- CWE601758S
- CWE600712S
- CWE602003S
- CWE600626S
- CWE600766S
- CWE601482S
- CWE601602S
- CWE602520S
- CWE602570S
- CWE602622S
- CWE601590S
- CWE602288S
- CWE601918S
- CWE602150S
- CWE602184S
- CWE602565S
- CWE602589S
- CWE600926S
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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