Agency classClass IIOur severity:High FDA (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.

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: 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: material-hardening
access-obstruction
pump-stop-risk
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 →

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

Same hazard · material hardening