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.
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 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.
- Affected units
- 5
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
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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