The Recall Desk
HighFDA (Devices)·Z-0748-2023·Announced 2022-12-28

HeartWare HVAD Pump Kit driveline cover hardening may impair urgent access

HeartWare HVAD Pump Kit driveline covers may harden over time, making them difficult to remove for urgent servicing. In an emergency scenario requiring driveline access, delays could harm patients.

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 with no reported illnesses or injuries. The hazard is a mechanical defect (driveline cover hardening) that could delay urgent access to critical device components, creating potential for patient harm in emergency scenarios, though actual harm has not been documented.

Plain-English summary

HeartWare HVAD Pump Kit (REF 1104JP) is a ventricular assist device implanted in patients with heart failure. Specifically, 73 units with the affected serial numbers are being recalled due to a mechanical defect in the driveline cover component.

The driveline cover may become hardened over time. When hardened, the cover becomes difficult or impossible to slide back, which prevents access to the driveline-to-controller connector. If a patient requires urgent servicing of the driveline connection or controller, delays in accessing this connector could result in prolonged pump stoppage and potential patient harm.

The product has been distributed worldwide. Patients and healthcare providers with affected devices should contact their Medtronic field representative immediately for assessment and servicing of the hardened cover. No illnesses or injuries related to this defect have been reported to the FDA to date.

The recalled product

Product
HeartWare HVAD Pump Kit, REF 1104JP
Manufacturer
Heartware, Inc.
Category
Medical Device — Ventricular Assist Device
Hazard
Affected units
73

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: HW40657
  • HW40658
  • HW40659
  • HW40660
  • HW40662
  • HW40663
  • HW40664
  • HW40665
  • HW40666
  • HW40667
  • HW40668
  • HW40789
  • HW40816
  • HW40881
  • HW40950
  • HW40951
  • HW40953
  • HW40954
  • HW40956
  • HW40957

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 · mechanical defect

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