FDA Enforcement
Class II
Ongoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Recall: Z-0475-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0475-2024
- Event ID
- 93405
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Heartware, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 13, 2023
- Initiation Date
- October 31, 2023
- Classification Date
- December 1, 2023
- Address
- 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States
Description
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Reason
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
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
Distribution
Worldwide
Quantity
45 units