Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
Medtronic is recalling 14 units of EVERA MRI S VR SureScan implantable cardioverter defibrillators (Model DVMC3D4) due to potential weld cracks discovered during manufacturing. No patient injuries have been reported.
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: FDA Class II medical device recall for a manufacturing defect (weld cracks) in an implantable cardioverter defibrillator that poses a potential risk of device failure. No patient injuries have been reported, and defects were identified during manufacturing quality control testing, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling the EVERA MRI S VR SureScan Model Number DVMC3D4, an implantable cardioverter defibrillator (ICD). The recall involves 14 units affected by a manufacturing defect involving potential weld cracks. These weld cracks caused devices to fail quality control testing during the manufacturing leak check phase.
The affected devices were distributed worldwide. In the United States, distribution included California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia. The devices were also distributed to Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
No patient injuries have been reported in connection with this defect. The manufacturing defect was identified during quality control testing.
The recalled product
- Product
- EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 14
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 (15)
- GTIN: 00763000206208
- Serial Number: PMZ646287S
- PMZ646288S
- PMZ646289S
- PMZ646291S
- PMZ646292S
- PMZ646295S
- PMZ646299S
- PMZ646300S
- PMZ646302S
- PMZ646303S
- PMZ646304S
- PMZ646305S
- PMZ646306S
- PMZ646307S.
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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