The Recall Desk
HighFDA (Devices)·Z-0750-2023·Announced 2022-12-28

HeartWare HVAD Pump Kit driveline cover hardening affects connector access

Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.

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 recall of a life-sustaining implanted cardiac device. Although no illnesses or injuries have been reported, the mechanical hardening could delay access to critical connectors during emergencies, creating a high-risk condition. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The HeartWare HVAD Pump Kit (REF MCS1705PU) is a mechanical cardiac pump used to support patients with heart failure. A total of 146 units worldwide have been affected by this recall.

The driveline cover—a protective component providing access to the driveline-to-controller connector—may harden over time. When hardened, the cover cannot be slid back to access the connector, making it difficult or impossible to reach.

This hardening may delay access to the driveline connector if urgent repairs or troubleshooting are needed. A delayed response to controller or driveline issues could result in a prolonged pump stop, which poses a risk to patients who depend on the pump for cardiac support.

If a hardened driveline cover is observed, patients and healthcare providers should contact their Medtronic field representative for further assessment and servicing.

The recalled product

Product
HeartWare HVAD Pump Kit, REF MCS1705PU
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Support Device
Hazard
Affected units
146

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 008887070090441
  • Serial Numbers: HW41765
  • HW42068
  • HW42069
  • HW42070
  • HW42071
  • HW42081
  • HW42082
  • HW42083
  • HW42176
  • HW42179
  • HW42184
  • HW42195
  • HW42202
  • HW42205
  • HW42261
  • HW42267
  • HW42297
  • HW42298
  • HW42301

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 →