The Recall Desk
HighFDA (Devices)·Z-0746-2023·Announced 2022-12-28

HeartWare HVAD Pump Kit Driveline Cover Hardening Issue

HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.

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 Class II device recall with no reported illnesses or injuries. The hazard is a risk-of-harm product (potential delayed access to driveline connector in a life-sustaining cardiac device) where injury has not yet been reported, meeting the High-level rubric criterion.

Plain-English summary

The HeartWare HVAD Pump Kit, REF 1104 (UDI/DI 00888707006323), is subject to this recall. Approximately 10,320 units have been distributed worldwide.

Over time, the driveline cover on the pump kit may become hardened. This hardening creates difficulty or an inability to slide the cover back to access the driveline-to-controller connector.

If urgent access to the driveline connector is needed to address a driveline connection or controller issue, a hardened cover could delay necessary servicing. This delay may result in patient harm from prolonged pump stoppage.

Patients and healthcare providers who observe a hardened driveline cover should contact their Medtronic field representative for further assessment and servicing.

The recalled product

Product
HeartWare HVAD Pump Kit, REF 1104
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
Affected units
10,320

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)

  • UDI/DI 00888707006323
  • Serial Numbers: HW25347
  • HW26099
  • HW26126
  • HW26274
  • HW26281
  • HW26330
  • HW26332
  • HW26660
  • HW26762
  • HW26939
  • HW26940
  • HW26969
  • HW27069
  • HW27099
  • HW27154
  • HW27184
  • HW27596
  • HW27674
  • HW27678

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.

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Same hazard · material hardening

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