EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x

FDA device recall Z-2320-2026 · posted 2026-06-05 · Open, Classified

Recall details

Recalling firm

BERLIN HEART GMBH

Reason for recall

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

Action taken

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

Root cause

Error in labeling

Status

Open, Classified

Product code

DSQ

Quantity affected

3

Distribution

US Nationwide distribution in the states of MA, SC.

Date initiated

2026-04-24

Date posted

2026-06-05

Location

Berlin, Germany