Reported Jan 10, 2024 · Ongoing
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to…
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Lot codes and dates
- UDI-DI 00813502011647 Software version 1.1 - 3.17.1
- Amount recalled
- n/a - no physical product
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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