BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 22 recalls
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.