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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT… recallZ-0475-2024 · Heartware, Inc. · initiated Oct 31, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling design

What the company is doing

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).

Recall details

Recall number
Z-0475-2024
Status
Open, Classified
Initiated by the company
Oct 31, 2023
Posted by the FDA
Dec 2, 2023
Recalling firm
Heartware, Inc.
Quantity
45 units
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide

Product description

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93405).

Sources and updates

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