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Class 2 Device Recall Heartware |
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Date Initiated by Firm |
October 31, 2023 |
Date Posted |
December 02, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0475-2024 |
Recall Event ID |
93405 |
PMA Number |
P100047 |
Product Classification |
Ventricular (assist) bypass - Product Code DSQ
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Product |
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Heartware, Inc. 14400 Nw 60th Ave Miami Lakes FL 33014-2807
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For Additional Information Contact |
MCS Customer Service 877-367-4823
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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
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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 |
45 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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PMA Database |
PMAs with Product Code = DSQ and Original Applicant = Medtronic
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