Heartware recalls updated instructions for use and patient manuals for HVAD System components to address carrying case orientation, driveline cover safety, and power-up sequence clarity. These updates prevent potential misuse of the critical heart failure support device.
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 support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being 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 that 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. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604
Heartware is recalling updated instructions for use and patient manuals for their HVAD heart failure support system. These updates clarify how to safely handle carrying cases, properly orient the driveline cover, and follow the correct power-up sequence to avoid potential misuse of this critical medical device.
The updates address potential confusion about carrying case orientation, driveline cover placement during connections, and the power-up sequence that could cause alarm indicators to activate. These clarifications help prevent misinterpretation of instructions that might lead to improper use of the life-supporting device.
Patients using Heartware's HVAD System for heart failure support, particularly those with the listed model numbers and serial numbers. Those most at risk are users who may have misinterpreted the instructions leading to improper handling of the device components.
Check if you own the Heartware HVAD System components with model numbers listed in the recall notice, including the HVAD Sterile Implant Kit (models 1100-1104, 1205, MCS1705PU), HVAD Controller Kit (models 1403US-1420), and other specified components. The recall applies to all units with the listed model numbers and serial numbers.
Check the updated Instructions for Use and Patient Manual for Heartware HVAD System components to ensure you have the latest version addressing carrying cases, driveline cover orientation, and power-up sequence.
Heartware is updating the instructions for use and patient manuals to clarify carrying case orientation, driveline cover placement, and power-up sequence to prevent potential misuse of the critical heart failure support device.
No action is required for the device itself, but you should review the updated instructions and patient manuals to ensure proper use of the Heartware HVAD System components.
The recall includes Heartware HVAD System components with specific model numbers listed in the notice, including HVAD Sterile Implant Kit (models 1100-1104, 1205, MCS1705PU), HVAD Controller Kit (models 1403US-1420), and other specified components.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1426-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1426-2021 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
