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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Category
- Medical Device — Cardiac Implant
- Hazard
- device-malfunction
- therapy-failure
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03