FDA-Device2026-06-17Class IIPACKAGING DEFECT
Berlin Heart EXCOR Pediatric VAD Blood Pump recalled for mismatched expiration dates
What this means
Some Berlin Heart EXCOR Pediatric Ventricular Assist Device blood pumps have mismatched expiration dates between the inner and outer package labels. The inner package shows an incorrect expiration date, which could cause confusion and delay surgical procedures if the device is not used on time.
- Check the inner and outer package expiration dates on any EXCOR Pediatric blood pump (10 ml or 30 ml) in your facility.
- Contact Berlin Heart or your device supplier immediately if you have an affected unit.
- Do not use the device until you have confirmed the correct expiration date with the manufacturer.
The agency's original wording
Hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Intended for
Children (under 18 years)
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MA, SC.
Affected count
3
Manufactured in
Wiesenweg 10, N/A, Berlin, N/A, Germany
Products
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2026Want us to check the next one for you?
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