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Open, Classified

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

FDA Recall Z-0636-2024 · Posted 2024-01-04

Recalling FirmAbiomed, Inc.
Recall StatusOpen, Classified
Product CodePYX
Date Initiated2023-12-06
Product Quantityn/a - no physical product

Reason for Recall

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

Firm Action

On December 6, 2023, the firm notified affected customers via a Correction Letter delivered by the ImpellaConnect.com portal. Customers were informed that the affected features were disabled from the web-based portal. If you have questions or concerns regarding this notice, please contact [email protected] and/or your local clinical field staff.

Root Cause

No Marketing Application

Distribution Pattern

Domestic distribution nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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