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U.S. Department of Health and Human Services

Class 2 Device Recall EXCOR Pediatric VAD system

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 Class 2 Device Recall EXCOR Pediatric VAD systemsee related information
Date Initiated by FirmApril 24, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2320-2026
Recall Event ID 98797
PMA NumberP160035 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Code Information REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
FEI Number 3004582654
Recalling Firm/
Manufacturer		 BERLIN HEART GMBH
Wiesenweg 10
Berlin Germany
For Additional Information ContactLuis Avila
281-863-9712
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionOn 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
Quantity in Commerce3
DistributionUS Nationwide distribution in the states of MA, SC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = DSQ
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