Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote

FDA device recall Z-0636-2024 · posted 2024-01-04 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

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

Action taken

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 ImpellaConnect@abiomed.com and/or your local clinical field staff.

Root cause

No Marketing Application

Status

Open, Classified

Product code

PYX

Quantity affected

n/a - no physical product

Distribution

Domestic distribution nationwide.

Date initiated

2023-12-06

Date posted

2024-01-04

Location

Danvers, MA