FDA Medical Device Recalls (openFDA)
BERLIN HEART GMBH: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Recall number
- Z-2320-2026
- Recalling firm
- BERLIN HEART GMBH
- Product
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Status
- Open, Classified
- Initiated
- 2026-04-24
- Posted
- 2026-06-05
- Terminated
- not on file
- Reason
- Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
- Root cause
- Error in labeling
- Action
- 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
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of MA, SC.
- Lot, serial or model codes
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
- 510(k) numbers
- not on file
- PMA numbers
- ["P160035"]
- Product code
- DSQ
- Firm FEI
- 3004582654
- Firm city
- Berlin
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28