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.
FDA Recall Z-1618-2023 · Posted 2023-05-25
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Recalling FirmBERLIN HEART GMBH
Recall StatusTerminated
Product CodeDSQ
Date Initiated2018-05-18
Date Terminated2024-06-06
Product Quantity335 units
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.
Firm Action
On May 18, 2018, Berlin Heart issued a Safety Communication via E-Mail to affected consignee. The Safety Communication asked consignees to take the following actions:
1. Always follow the information and instructions provided in the Instructions for Use that have been provided to you by Berlin Heart. Information related to the specific issues discussed within the letter is included in Chapter 12 starting on page 115, specifically Section 12.5, and 12.51.
2. Additional information on troubleshooting is found in Chapter 16 starting on page 161.
3. If you have any questions or concerns regarding the communication, please contact Clinical Affairs team directly at 281-863-9700
Root Cause
Component design/selection
Distribution Pattern
Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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