EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Recall
- Recall Number
- Z-2320-2026
- Event Number
- 98797
- Firm
- BERLIN HEART GMBH Wiesenweg 10 Berlin Germany
- FEI Number
- 3004582654
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- April 24, 2026
- Posted
- June 5, 2026
Description
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
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 [email protected] If you have questions, contact the firm at [email protected] or 888-826-9466
US Nationwide distribution in the states of MA, SC.
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