EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump);

FDA device recall Z-1618-2023 · posted 2023-05-25 · Terminated

Recall details

Recalling firm

BERLIN HEART GMBH

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.

Action taken

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

Status

Terminated

Product code

DSQ

Quantity affected

335 units

Distribution

Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada

Date initiated

2018-05-18

Date posted

2023-05-25

Date terminated

2024-06-06

Location

Berlin, Germany