Implantable Cardioverter Defibrillator with Weld Crack Defect Recalled
Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.
- Product
- EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
- Category
- Medical Device
- Distribution
- Distributed nationwide