EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
FDA device recall Z-2199-2024 · posted 2024-06-26 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc.
- Reason for recall
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Action taken
- On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LWS
- Quantity affected
- 40 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic
- Date initiated
- 2024-04-16
- Date posted
- 2024-06-26
- Location
- Mounds View, MN
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