Recall Z-0748-2023 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104JP
| Date | Dec 21, 2022 (initiated Nov 29, 2022) |
| Status | Open, Classified |
| Reason | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing. |
| Root cause | Device Design |
| Action | The firm issued an URGENT: MEDICAL DEVICE COMMUNICATION to the healthcare providers on 11/29/2022 by UPS 2-day delivery. The letter explained the issue and provided the following: "A. Patient Management Recommendations: In consultation with our Independent Practitioner Quality Panel, Medtronic is providing the following patient management recommendations: "Prior to exchanging a controller in the clinic, check to ensure the driveline cover is not stuck or hardened and can be pulled back from the driveline connector, per the instructions below.This may allow for early detection of the issue |
| Quantity | 73 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.