Device product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Z-2320-2026
Product summary
- Event
- Event 98797
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2320-2026
Official wording
Reason: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Code information: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Distribution pattern: US Nationwide distribution in the states of MA, SC.
Derived failure modes
-
Unknown
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.