The Recall Desk
HighFDA (Devices)·Z-0745-2023·Announced 2022-12-28

HeartWare HVAD Pump Kit driveline cover may harden, impeding urgent access

The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.

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 an FDA Class II device recall with no reported illnesses or injuries. The hazard is a life-sustaining device where a manufacturing defect (cover hardening) could prevent urgent access to critical connectors. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

HeartWare, Inc. is recalling the HeartWare HVAD Pump Kit, model REF 1103 (5704 units worldwide distributed). The recalled kits are identified by UDI/DI 00888707003261 and specific serial numbers beginning with HW.

The driveline cover on these pump kits may become hardened over time. When hardened, the cover cannot be easily or at all slid back to access the driveline to controller connector, which is a critical interface for device function and maintenance.

Delayed access to the driveline connector may prevent prompt intervention if a patient requires urgent driveline connection troubleshooting or controller assessment. Since the HVAD is a life-sustaining heart-assist device, any delay in addressing urgent issues could result in patient harm from a prolonged pump stop.

If a hardened driveline cover is observed on your HeartWare HVAD Pump Kit, contact your Medtronic field representative for further assessment and servicing.

The recalled product

Product
HeartWare HVAD Pump Kit, REF 1103
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
Affected units
5,704

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 00888707003261
  • Serial Numbers: HW11011
  • HW11013
  • HW11019
  • HW11033
  • HW11036
  • HW11047
  • HW11060
  • HW11064
  • HW11067
  • HW11074
  • HW11075
  • HW11078
  • HW11086
  • HW11088
  • HW11094
  • HW11106
  • HW11107
  • HW11112
  • HW11113

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 · material hardening

See all →