Z-2320-2026Class II

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

Name: Z-2320-2026 EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml...
Creator: Berlin Heart Gmbh
Published: 2026-04-24
License: https://open.fda.gov/license/

Berlin Heart GmbH / initiated 2026-04-24 / Open, Classified / root cause: labeling and UDI

FDA source

BERLIN HEART GMBH began a recall of EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 on 2026-04-24. FDA classified it as Class II and gives the reason as "Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2320-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-24
Posted: 2026-06-05
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
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] If you have questions, contact the firm at [email protected] or 888-826-9466
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of MA, SC.
Product codes and lots: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2320-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)