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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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.
- Affected units
- 1
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
Part of a larger recall action
This product is one of 23 recalled by Medtronic Inc. 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.
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