Medtronic EVERA S VR Implantable Cardioverter Defibrillator Recalled for Manufacturing Defect
Medtronic is recalling EVERA S VR implantable cardioverter defibrillators due to a potential manufacturing defect involving a weld crack that can cause device failure. The defect was identified during manufacturing leak testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a confirmed manufacturing defect (weld crack causing device failure during manufacturing testing). Although the defect was identified and contained before patient implantation, the device is a life-critical implantable cardioverter defibrillator. Per the severity rubric, risk-of-harm products without reported patient injuries are classified as High.
Plain-English summary
Medtronic Inc. is recalling the EVERA S VR, Model Number DVBC3D1, an implantable cardioverter defibrillator (ICD). The recall is due to a potential manufacturing defect—specifically, a weld crack—that could cause device failure. The defect was identified during manufacturing testing when devices failed leak check procedures.
The affected device has been distributed worldwide, including throughout the United States and internationally to over 40 countries. This is a Class II recall issued by the FDA.
The recalled product
- Product
- EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- manufacturing-defect
- weld-defect
- device-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 (2)
- GTIN: 00763000740559
- Serial Number: BWM614493S
Distribution
Distributed nationwide across the United States.
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