Abiomed recalls Impella Connect software portal version 1.1-3.17.1 due to disabled safety features. Users may face risks from unmonitored device alerts.
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Abiomed is recalling its Impella Connect software portal for online device management. The recall is because certain safety features were disabled by the FDA before approval, which could lead to missed alerts about device issues.
The software portal has safety features like email notifications and alarm color indicators disabled. Without these, clinicians might miss critical device alerts, potentially leading to unsafe conditions.
Clinicians and Impella support staff who use the Impella Connect software portal for remote device monitoring are affected. Those who rely on the disabled safety features for alerts are at higher risk.
Check for the software version 1.1 to 3.17.1 on the Impella Connect portal. The product is sold by Abiomed for remote device management use.
Verify your Impella Connect software version is 1.1 to 3.17.1.
The FDA disabled certain safety features in the software portal before approval, which could lead to missed device alerts.
Check your software version; if it's 1.1 to 3.17.1, you should verify if you need to update or contact Abiomed.
The recall record does not specify a fix or remedy for this software version.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0636-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0636-2024 from Abiomed. 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.
