The Recall Desk
ModerateFDA (Devices)·Z-0481-2024·Announced 2023-12-13

Ventricular Assist Device Instructions Updated for Alarm and Useful Life Clarification

Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a voluntary documentation update to clarify operational instructions for a life-sustaining device. Although the device is critical, the recall is precautionary in nature, addressing instruction clarity rather than a product defect, with no reported illnesses or injuries in the source material.

Plain-English summary

Heartware, Inc. is issuing updated instructions for use (IFU) and patient manuals for the PUMP 1104 HVAD ventricular assist device implant kits. The updates will clarify the conditions under which the HVAD Controller Fault alarm may sound and provide recommended troubleshooting actions for patients and healthcare providers. The updates also include new instructions relating to the useful life of HVAD system components.

The recall affects 126 units with specific serial numbers distributed worldwide. This is an FDA Class II recall. Patients and healthcare providers with affected HVAD implants should review the updated instructions and materials when they become available from the manufacturer.

The recalled product

Product
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Manufacturer
Heartware, Inc.
Category
Medical Device — Ventricular Assist 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)

  • GTIN none
  • Serial Numbers: HW25172
  • HW25169FSCA
  • HW25170FSCA
  • HW25174FSCA
  • GTIN 00763000170967
  • Serial numbers: HW42722
  • HW42771
  • HW42285
  • HW41696
  • HW41675
  • HW40953
  • HW41848
  • HW41847
  • HW41316
  • HW41828
  • HW41824
  • HW41803
  • HW41670
  • HW41271

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 →

Related recalls

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Same hazard · alarm confusion

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