Use cautionMedical device recall · FDA · Published December 6, 2023
Abiomed Impella Connect Software Recall: Disabled Safety Features
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
Take action
Contact the company
📍Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed Impella Connect Software Recall: Disabled Safety Features.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56620-abiomed-impella-connect-software-recall-disabled-safety-features. Based on FDA recall #Z-0636-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0636-2024%22&limit=1).
Abiomed, Inc. voluntarily recalled the Impella Connect software portal on Dec. 6, 2023, according to the FDA. The agency said it disabled several features because they were not evaluated for safety and effectiveness.
How to tell if you have it
Brand: Abiomed
Product: Impella Connect
Description: Software portal for online device management
UDI-DI: 00813502011647
Software version: 1.1 - 3.17.1
The hazard
The FDA has not evaluated the following features for safety and effectiveness: notifications via email, AIC alarm color on case tile, sorting case tiles by AIC alarm color, and pump metric display on case tile. These features have been disabled from the web-based portal.
Context
GovInfoNow's records show Abiomed, Inc. has issued 28 other recalls since Sept. 4, 2019. Recent brand recalls include an Aug. 12, 2026 recall for Impella Controller purge cassette recognition issues and a June 11, 2026 recall for Impella CP Smart Assist Set introducer sheath leakage risk. Other recent recalls of similar products include the March 23, 2026 Hologic Genius Review Station Display Recall and the Oct. 24, 2025 Edan Central Monitoring System Recall.
How to tell if you have this one
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.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Impella Connect software version is 1.1 to 3.17.1.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0636-2024 (December 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0636-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.