The Recall Desk
HighFDA (Devices)·Z-0747-2023·Announced 2022-12-28

HeartWare HVAD Pump Kit driveline cover hardening may prevent repairs

A hardened driveline cover on the HeartWare HVAD Pump Kit may prevent or delay access to the driveline to controller connector. If urgent servicing is needed, the delay could result in patient harm from pump malfunction.

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: This is a risk-of-harm medical device where no injuries have been reported. The mechanical defect creates genuine risk of patient harm by delaying access to critical connections on a cardiac support device, potentially causing prolonged pump shutdown in urgent situations. This meets the High severity criterion for risk-of-harm products without reported injuries.

Plain-English summary

Heartware, Inc. is recalling six units of the HeartWare HVAD Pump Kit (model REF 1104CA-CLIN) with serial numbers HW24101, HW24102, HW24103, HW24104, HW24755, and HW24763 due to a mechanical defect affecting the driveline cover.

Over time, the driveline cover may become hardened, making it difficult or impossible to slide the cover back to access the driveline to controller connector. This mechanical degradation can occur with normal use of the device.

The hardened cover can delay access to the connector, which may result in patient harm if an urgent driveline connection or controller issue needs to be addressed and the pump must be stopped. Patients with affected units should contact their Medtronic field representative immediately if they experience difficulty accessing the driveline connector or if servicing is needed.

This device has been distributed worldwide. Patients and healthcare providers managing patients with this device should verify the serial number against the recall list and seek assessment or servicing if necessary.

The recalled product

Product
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac / Ventricular Assist Device
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
  • HW24755
  • HW24763

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

Same manufacturer · Heartware, Inc.

See all →

Same hazard · mechanical defect

See all →