Official recall notice
FDA DeviceClass IINotable
FDA Recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 3
- Recall date
- 2026-06-17
- Brand
- BERLIN HEART GMBH
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Recommended action
What to do
3
Product description
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.