Recall Z-0946-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
| Date | Feb 4, 2021 (initiated Nov 19, 2020) |
| Status | Open, Classified |
| Reason | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population. |
| Root cause | Under Investigation by firm |
| Action | On 11/19/2020, notifications initiated to inform about recall. Additional notifications sent on 5/18/2022 (https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-june-2022.pdf), 10/13/2022 and May 08, 2024. On 8/20/2025, communications initiated to inform about algorithm C controller that will attempt to pump restart using algorithm A, and if needed algorithm B. It will mitigate controller resetting. Blue line highlights on algorithm C controller exterior differentiates it from previous versions. Healthcare providers asked to speak |
| Quantity | 19,562 units |
| Distribution | Worldwide - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.