# FDA recall Z-1618-2023

> **BERLIN HEART GMBH** · Class I · device recall initiated 2018-05-18.

## Product

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-001 (60 ml blood pump).  Recall occurred in 2018, and was retrospectively reported.

## Reason for recall

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

## Key facts

- **Recall number:** Z-1618-2023
- **Recalling firm:** BERLIN HEART GMBH
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-18
- **Report date:** 2023-05-31
- **Termination date:** 2024-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2023

## Citation

> AI Analytics. FDA recall Z-1618-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1618-2023. Source: US FDA. Licensed CC0.

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