The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0482-2024·Announced 2023-12-13

HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan

Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves a risk-of-harm product (implanted ventricular assist device) where no injuries have been reported. The recall addresses instructional clarity regarding critical device functions. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model 1205, is subject to a Class II recall affecting 126 units distributed worldwide. Heartware, Inc., the manufacturer, is providing updated instructions for use (IFU) and patient manual materials.

The updates are intended to clarify the conditions under which the HVAD controller fault alarm may sound and to provide recommended troubleshooting actions. The updates will also clarify instructions relating to the useful life of HVAD system components.

Patients who have received the HVAD implant should consult with their healthcare provider regarding any questions about these updated instructions or device operation.

The recalled product

Product
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Manufacturer
Heartware, Inc.
Category
Medical Device — Implanted Cardiac Device
Hazard
Affected units
126

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: HW1412
  • HW1413
  • HW1416
  • HW1433
  • HW1435
  • HW1490
  • HW1493
  • HW1495
  • HW1496
  • HW1593
  • HW1599
  • HW1641
  • HW1661
  • HW1662
  • HW1663
  • HW1664
  • HW1695
  • HW1696
  • HW1698
  • HW1699

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 9 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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