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EXCOR Pediatric Ventricular Assist Device (VAD) System… recallZ-2320-2026 · Berlin Heart GMBH · initiated Apr 24, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Berlin Heart GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-2320-2026
Status
Open, Classified
Initiated by the company
Apr 24, 2026
Posted by the FDA
Jun 5, 2026
Recalling firm
Berlin Heart GMBH
Quantity
3
Product code
DSQ
FDA submissions
P160035
Distribution
US Nationwide distribution in the states of MA, SC.

Product description

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Code information (models, lots, serial numbers)

REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

19 devices cleared under P160035 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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