Heartware recalls updated instructions for HeartWare HVAD system to address alarms that resolve quickly, which may indicate intermittent issues needing clinician evaluation.
IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604
Heartware is updating its instructions for use and patient manual for HVAD pumps to help users recognize when alarms that clear quickly might signal intermittent problems. This update is important because patients should contact their healthcare provider if they can't identify the cause of an alarm before it stops.
Alarms that resolve very quickly may indicate an intermittent issue with the device that requires analysis of controller logs. If patients don't identify the alarm before it clears, they might miss a problem that needs clinical evaluation.
Patients with Heartware HVAD pumps (models 1100-1205, MCS1705PU, and related components) who follow the updated instructions. Those most at risk are patients who experience frequent alarms that resolve quickly without understanding the cause.
Check if your Heartware HVAD pump or related components (like controller kits, batteries, or cables) have model numbers listed in the recall: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU, or other specified models. All units were updated as of February 26, 2021.
Check the updated Instructions for Use and Patient Manual for guidance on interpreting alarms that resolve quickly.
The update helps clinicians and patients understand that alarms resolving after a short period may indicate intermittent problems requiring analysis of controller logs.
No action is needed for the device itself, but patients should review the updated instructions if they experience alarms that resolve quickly.
Contact your healthcare provider if you cannot identify the cause of the alarm before it clears, as this may indicate an intermittent issue.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1469-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1469-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
