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.

On 4/24/2026, recall notices were emailed to customers who were asked to do the following: 1) Segregate and discontinue use of any affected unused product. 2). Notify all appropriate personnel within your organization who need to be aware of this recall. 3) If any affected devices have been transferred to another facility or customer, promptly forward this notification to those accounts. 4) Firm will provide replacement products for the affected mislabeled devices and will issue a return shipping label so affected unused products may be returned through the Return Goods Authorization (RGA) process. 5) Complete, sign, and return the attached Acknowledgement Form by email to info@berlinheartinc.com If you have questions, contact the firm at info@berlinheartinc.com or 888-826-9466

• FDA enforcement recordOfficial FDA database entry for Z-2320-2026
• FDA device classification · DSQOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BERLIN HEART GMBHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.