FDA recall Z-2320-2026

Product

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

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.

Distribution

US Nationwide distribution in the states of MA, SC.

Key facts

Status

Ongoing

Initiation date

2026-04-24

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2026