Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: mechanical-defect
access-delay
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 →

Same manufacturer · Heartware, Inc.

See all →

High
HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
Moderate
HeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
High
Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications
FDA (Devices) · 2023-12-13
High
HVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
High
HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13

Same hazard · mechanical defect