Medtronic Implantable Cardioverter Defibrillator Recalled Due to Weld Crack Defect
Medtronic is recalling 6 units of the MIRRO MRI VR SureScan implantable cardioverter defibrillator due to a potential manufacturing defect. The devices failed manufacturing quality checks because of a weld crack.
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 an FDA Class II implantable device recall involving a manufacturing defect in a life-critical cardiac device. Although no illnesses, injuries, or deaths have been reported and defective units were detected during manufacturing quality control, the potential risk posed by a weld crack in an implantable cardioverter defibrillator warrants a High severity classification.
Plain-English summary
Medtronic Inc. is recalling 6 units of the MIRRO MRI VR SureScan, Model Number DVME3D1, an implantable cardioverter defibrillator (ICD). The recall addresses a potential manufacturing defect involving a weld crack in the affected devices.
During manufacturing, these devices failed the leak check step, which is designed to verify the integrity of the sealed enclosure. The weld crack could compromise the protective seal of the device and affect its safety and reliability.
The affected units have the following serial numbers: CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, and CWP605658S. These devices were distributed worldwide to multiple countries and across numerous US states.
If you have received or been implanted with one of these devices, contact your healthcare provider or Medtronic immediately for guidance. Do not delay seeking medical evaluation if you experience any symptoms related to your device.
The recalled product
- Product
- MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- manufacturing-defect
- weld-crack
- 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 (7)
- GTIN: 00763000611972
- Serial Numbers: CWP605601S
- CWP605619S
- CWP605620S
- CWP605653S
- CWP605654S
- CWP605658S.
Distribution
Distributed nationwide across the United States.
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