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.
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: "Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the…"
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…
- 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.
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