Agency classClass IOur severity:Severe FDA (Devices)·Z-2057-2020·Announced 2020-06-03

Heartware HVAD Pump Implant Kit Recalled for Graft and Screw Defects

Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump."

Plain-English summary

Heartware, Inc. is recalling 85 units of the Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP. The recall covers units distributed worldwide with specific GTINs and serial numbers listed in the agency record.

The recall is due to a manufacturing defect where the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. This defect poses a risk of device failure during the surgical preparation process.

Healthcare providers and patients should contact Heartware, Inc. for further instructions regarding the affected units. The source text does not specify a particular consumer action beyond the recall notification, but medical professionals should verify if any of the listed serial numbers are in their inventory or patient records.

The recalled product

Product: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Manufacturer: Heartware, Inc.
Category: Medical Device — Cardiovascular Implant
Hazard: device-failure
structural-defect
Affected units: 85

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)

GTIN 00888707000697
Serial numbers: HW34700
HW34703
HW34710
HW34713 GTIN 00888707005838
Serial Numbers: HW40383
HW40412
HW40413
HW40414
HW40415
HW40417
HW40418
HW40419
HW40420
HW40421
HW40422
HW40423
HW40424
HW40425
HW40426

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 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 5 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 · device failure