Recall Z-1438-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| Reason | IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603 |
| Root cause | Device Design |
| Action | Beginning 26-Feb-2021, an Urgent Medical Device Recall notification was disseminated to consignees who Medtronic records indicate have received affected product, UPS 2-day delivery. The notices provided updated information for the instructions for use and patient manual. |
| Quantity | 23123 (11292 US) |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.