Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect
Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.
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 with potential manufacturing defect in a high-risk implantable device. Applies rubric criterion: 'risk-of-harm product where injury has not yet been reported' (Score 3). The weld defect was detected during manufacturing quality control.
Plain-English summary
Medtronic Inc. is recalling 13 MIRRO MRI VR SureScan Model DVME3D4 implantable cardioverter defibrillators (ICDs). The affected devices are identified by 13 specific serial numbers (CWR621520S through CWR621532S).
The recall is due to a potential manufacturing defect involving a weld crack. This defect was identified during the manufacturing leak check step, a quality control test designed to verify device integrity. The weld crack caused the affected devices to fail this manufacturing test.
The affected devices were distributed internationally, including to the United States in California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia, as well as to multiple countries worldwide.
No illnesses or injuries related to this defect have been reported. Medtronic is coordinating with healthcare providers to address the affected devices identified by their serial numbers.
The recalled product
- Product
- MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 13
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 (14)
- GTIN: 00763000611989
- Serial Numbers: CWR621520S
- CWR621521S
- CWR621522S
- CWR621523S
- CWR621524S
- CWR621525S
- CWR621526S
- CWR621527S
- CWR621528S
- CWR621529S
- CWR621530S
- CWR621531S
- CWR621532S.
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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