HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
This recall is currently active, issued December 2, 2023. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- October 31, 2023
- Posted
- December 2, 2023
- Recall Number
- Z-0475-2024
- Quantity
- 45 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Distribution
Worldwide
Lot / 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
Root Cause
Labeling design
Action Taken
Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).