FDA Recall
Open, Classified
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Recall: Z-0480-2024
·
Initiated October 31, 2023
Recall
- Recall Number
- Z-0480-2024
- Event Number
- 93405
- Firm
- Heartware, Inc.
- FEI Number
- 3007042319
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- October 31, 2023
- Posted
- December 2, 2023
- Address
- 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807
Description
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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
Action
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).
Distribution
Worldwide
Quantity
6 units