Reported Jun 17, 2026 · Ongoing

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

Berlin Heart GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BERLIN HEART GMBH · Wiesenweg 10 · Berlin, N/A · N/A

Is this the product you have?

  • EXCOR Pediatric Ventricular Assist Device (VAD)
  • System Blood Pump PU Valves10 ml
  • REF
    • P10P-001
    • 30 ml
  • REFP30P-001x01
Lot codes and dates

2 of 2 products · 3 lot codes

Recalled lot codes, grouped by product number
REFUDI-DIserial number
P10P-00104260090040102
  • 2230714
  • 2230709
P30P-001x0104260090040126
  • 2230254
Amount recalled
3

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:38 PM UTC

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