Recall Z-1618-2023 ยท DSQ Ventricular (Assist) Bypass
BERLIN HEART GMBH
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.
| Date | May 25, 2023 (initiated May 18, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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 rega |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.