Heartware, Inc. Recall 91281
Description: HeartWare Model 1100
Heartware, Inc. Recall 91281 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0742-2023 |
| Event ID | 91281 |
| Event Description | HeartWare Model 1100 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 45 units |
| Recall 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. |
| Device Classification | 20221228 |
| Device Code Info | Serial Numbers: HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW104, HW105, HW108, HW109, HW110, HW114, HW115, HW116, HW119, HW126, HW127, HW129, HW130, HW131, HW138, HW139, HW143, HW146, HW147, HW153, HW156, HW161, HW170, HW181 |
| Center Classification Date | 20221221 |
| Recall Initiation Date | 20221129 |
| Recalling Firm | Heartware, Inc. |
| Initial Notification | Letter |
| Similar To |