Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1438-2021·Announced 2021-04-28

HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding device operation. As no injuries or illnesses are reported and the hazard is theoretical, it aligns with the Moderate severity criteria for minor labeling errors.

Plain-English summary

Heartware, Inc. is recalling the Instructions for Use and Patient Manual for the HeartWare HVAD System. The recall affects 23,123 units, including 11,292 in the United States, which were distributed nationwide and in Italy, Great Britain, Germany, and Japan.

The labeling is being corrected to accurately describe the behavior of a successful connection to the HVAD controller. The manual previously stated that a successful connection produces an "audible click," but the actual verified behavior is a "beep." The update clarifies the alarm conditions under which a beep will not be heard and identifies a visual indicator as an alternate method to confirm a successful connection.

This labeling update is also included in the February 2021 Urgent Medical Device Notice, which is covered in recalls 87456 and 87603. The recall is classified as Class II by the FDA.

The recalled product

Product: Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE…
Manufacturer: Heartware, Inc.
Category: Medical Device — Ventricular Assist Device
Hazard: mis-labeling

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)

Model
GTIN: 1100
No GTIN Available
1101
1102
1103
00888707000017
1104
1104JP
00888707000697
1205
MCS1705PU
00888707005364
1403US
00888707000475
1407AU
00888707001663
1407CA
00888707002851
1407CH

Distribution

Distributed nationwide across the United States.

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 · mis labeling