Moderate FDA (Devices)·Z-2320-2026·Announced 2026-06-17

EXCOR pediatric blood pump valves carry mismatched inner package expiration dates

EXCOR Pediatric VAD System blood pump PU valves are being recalled because the inner package expiration date does not match the correct outer package date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall arising from an inner-package date discrepancy, with the stated consequence being procedural delay rather than a product defect, which fits the Moderate band.

Plain-English summary

EXCOR Pediatric Ventricular Assist Device (VAD) System blood pump PU valves are being recalled, covering the 10 ml valve, REF P10P-001, and the 30 ml valve, REF P30P-001x01. The action covers three units.

The stated reason is that the blood pump inner package expiration date does not match the outer, correct expiration date, which according to the manufacturer may lead to delays in surgical procedures. The FDA classified the action as Class II. The source does not describe any defect in the valves themselves.

Distribution was within the United States, in Massachusetts and South Carolina. The valves are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF numbers, UDI-DI codes and serial numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Manufacturer: BERLIN HEART GMBH
Category: Medical Device — Ventricular assist device component
Hazard: labeling-error
expiration-date-mismatch
packaging
class-ii
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · BERLIN HEART GMBH

See all →

Critical
Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption
FDA (Devices) · 2023-05-31

Same hazard · labeling error