Recall Atlas

Berlin Heart recalls

2 official recalls and safety alerts involving Berlin Heart since 2023-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Berlin Heart or the relevant agency.

  1. 2026-06-17
  2. US
    Drugs & medicalClass II

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

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

    FDA · DeviceBERLIN HEART GMBHUS Nationwide distribution in the states of MA, SC.Official notice →
  3. 2023-05-31
  4. US
    Drugs & medicalClass I

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25…

    There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

    FDA · DeviceBERLIN HEART GMBHDistribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA,…Official notice →