Heartware recalls updated instructions for HVAD system to clarify controller connection verification using a beep instead of audible click. This correction helps users identify proper device connection without confusion.
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
Heartware is recalling the instructions for use and patient manual for their HVAD system to clarify how to verify successful connection to the controller. The update changes the description from an 'audible click' to a 'beep' sound, which helps users avoid misinterpreting connection status and potential device issues.
The original instructions described a successful controller connection as an 'audible click', but the actual verification is a 'beep'. If users mistakenly think they have a successful connection when it's not, they might not detect a problem with the device, potentially leading to improper function.
Patients with Heartware HVAD pump implants (models 1100-1205, MCS1705PU) and related controller kits, AC/DC adapters, and accessories. Those most at risk are users who might have misinterpreted the connection sound as a 'click' instead of a 'beep' due to outdated instructions.
Check if you own Heartware HVAD pump implant kits (models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU) or related controller kits, AC/DC adapters, and accessories listed in the recall notice.
Check the updated Instructions for Use and Patient Manual for Heartware HVAD System to confirm the correct connection verification method (beep, not audible click).
The recall updates the instructions to correctly describe that a successful controller connection produces a 'beep' sound, not an 'audible click', to prevent users from misinterpreting the connection status.
No action is required for the device itself. Only the instructions and patient manual need updating to clarify the connection verification method.
Affected models include Heartware HVAD pump implant kits (1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU) and related controller kits, AC/DC adapters, and accessories.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1438-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1438-2021 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.
