Berlin, N/A, Germany
BERLIN HEART GMBH recalls
2 recalls recorded since 2018, most recently on 24 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 24 April 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2320-2026
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Terminated Class I Medical devices
- Recall started
- 18 May 2018
- Terminated
- 6 June 2024
- Reason
- 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.
- Distribution
- Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1618-2023
- EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.