The Recall Desk
HighFDA (Devices)·Z-0749-2023·Announced 2022-12-28

HeartWare HVAD ventricular assist pump driveline cover hardening recall

HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, 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 recall of an implantable ventricular assist device. No injuries have been reported, making the harm theoretical. However, the product is a critical life-support device and the recall explicitly identifies risk of patient harm from delayed device servicing. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

This recall affects 126 HeartWare HVAD Pump Kit units (model REF 1205) distributed worldwide, manufactured by Heartware, Inc. The driveline cover—a component that protects the connection between the pump and the external controller—may become hardened over time.

A hardened driveline cover creates difficulty or inability to slide the cover back in order to access the driveline-to-controller connector. If an urgent driveline connection issue or controller malfunction requires immediate servicing, this impaired access could delay critical intervention, potentially resulting in patient harm from prolonged pump stoppage.

No injuries or illnesses have been reported to date. Heartware, Inc. recommends that healthcare providers or patients who observe a hardened driveline cover contact their Medtronic field representative for further assessment and service.

The recalled product

Product
HeartWare HVAD Pump Kit, REF 1205
Manufacturer
Heartware, Inc.
Category
Medical Device — Implantable 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)

  • 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 →

Related recalls

Same manufacturer · Heartware, Inc.

See all →