HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover
Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The action is a documentation update to clarify instructions and add useful life information, with no reported injuries or illnesses.
Plain-English summary
Heartware, Inc. is recalling the Instructions for Use (IFU) and Patient Manual (PM) for the HeartWare HVAD System. This recall involves 23,123 devices, including 11,292 in the United States, with worldwide distribution across numerous countries. The affected components include the HVAD Sterile Implant Kit, Controller Kit, AC and DC Adapter Controllers, Data Cables, Battery Packs, and various patient and waist/shoulder packs.
The recall is initiated to update the documentation regarding carrying cases, driveline cover orientation, and the controller power-up sequence. The Patient Manual is being updated to clarify the use of the support strap, wear instructions, and cleaning instructions for carrying cases. Additionally, a useful life for the carrying cases is being added to the IFU and PM. The PM is also updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline.
The IFU and PM are being updated to clarify the power-up sequence, which causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. This update is also included in the February 2021 Urgent Medical Device Notice covered in recalls 87603 and 87604.
The recalled product
- Product
- Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
- Manufacturer
- Heartware, Inc.
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Heartware, Inc.
See all →- HighHVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateHeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateVentricular Assist Device Instructions Updated for Alarm and Useful Life Clarification
FDA (Devices) · 2023-12-13
Same hazard · documentation error
See all →- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01