Date Initiated by Firm |
October 31, 2023 |
Date Posted |
December 02, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0480-2024 |
Recall Event ID |
93405 |
Product Classification |
Ventricular (assist) bypass - Product Code DSQ
|
Product |
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN |
Code Information |
Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
|
Recalling Firm/ Manufacturer |
Heartware, Inc. 14400 Nw 60th Ave Miami Lakes FL 33014-2807
|
For Additional Information Contact |
MCS Customer Service 877-367-4823
|
Manufacturer 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
|
FDA Determined Cause 2 |
Labeling design |
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). |
Quantity in Commerce |
6 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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