FDA DeviceClass IINotable

FDA Recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 3

Date: 2026-06-17
Brand: BERLIN HEART GMBH
Category: Medical Device
FDA Class: Class II

Description

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Hazard

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Remedy

3

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