The Recall Desk
HighFDA (Devices)·Z-0480-2024·Announced 2023-12-13

HVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan

Heartware recalls HVAD ventricular assist pump instructions to clarify controller fault alarm conditions and component useful life expectations.

What this means for you

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: FDA Class II recall of a critical life-sustaining cardiac device. The recall addresses potential confusion regarding controller fault alarm conditions and component useful life through instruction updates. No illnesses or injuries reported, but instruction ambiguities on a life-critical device present potential for patient harm.

Plain-English summary

Heartware, Inc. is recalling the HVAD (HeartWare Ventricular Assist Device) pump, Model 1104CA-CLIN (serial numbers HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA). Six units were distributed worldwide. This is a Class II medical device recall issued by the FDA.

The recall involves updates to the product's instructions for use (IFU) and patient manual. These updates will clarify the conditions under which the HVAD controller fault alarm may sound and provide recommended troubleshooting actions. The updates will also provide clarified instructions relating to the useful life of HVAD system components.

Patients using the HVAD ventricular assist device and their caregivers should refer to updated materials from Heartware, Inc. when they are available. Patients should contact their healthcare provider with questions about their device or if they experience any issues.

The recalled product

Product
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Support
Hazard
Affected units
6

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 (6)

  • Serial numbers: HW24101
  • HW24102
  • HW24103
  • HW24104
  • HW24763
  • HW24755FSCA

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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