Medtronic EVERA MRI implantable defibrillator recalled for manufacturing weld defect
Medtronic is recalling five units of its EVERA MRI S DR SureScan implantable cardioverter defibrillator due to a manufacturing defect—a weld crack that caused failure during quality control 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 medical device recall of a high-risk implantable cardioverter defibrillator with a potential structural defect (weld crack). Although no illnesses or injuries have been reported and the defect was identified during manufacturing, an ICD is a life-sustaining device where malfunction could cause serious harm.
Plain-English summary
Medtronic Inc. is recalling five units of the EVERA MRI S DR SureScan Model Number DDMC3D1, an implantable cardioverter defibrillator (ICD). The recall addresses a manufacturing defect identified during quality control testing.
The devices contain a weld crack that caused them to fail the leak check step during manufacturing. This defect could potentially lead to device malfunction if an affected unit were implanted.
The five affected devices have the following serial numbers: CWC613698S, CWC613700S, CWC613713S, CWC613715S, and CWC613717S. They were distributed in multiple U.S. states and internationally. Patients who believe they may have received one of these devices should contact their healthcare provider or Medtronic for verification and guidance.
The recalled product
- Product
- EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- 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 (6)
- GTIN: 00763000206192
- Serial Number: CWC613698S
- CWC613700S
- CWC613713S
- CWC613715S
- CWC613717S.
Distribution
Distributed nationwide across the United States.
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