Recall Z-1338-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Medtronic HVAD Alarm Adapter, Product Number: 1450
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| Reason | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port. |
| Root cause | Device Design |
| Action | The firm issued a Medical Device Notice to its consignees on 02/26/2021 by letter delivered via UPS 2-day delivery. The letter explained the issue and directed the physician to review the patient management recommendations on the frequency of of inspecting the HVAD Controller, HVAD Controller power cables, and HVAD Monitor data cables. For questions regarding this material, please contact your Medtronic Field Representative. |
| Quantity | 418 units (315 US) |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.