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Impella Connect, software portal for online device… recallZ-0636-2024 · Abiomed, Inc. · initiated Dec 6, 2023

Class II Open, Classified All recalls posted in January 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: No Marketing Application

What the company is doing

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.

Recall details

Recall number
Z-0636-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 6, 2023
Posted by the FDA
Jan 4, 2024
Recalling firm
Abiomed, Inc.
Quantity
n/a - no physical product
Product code
PYX
FDA submissions
P170011, P140003
Distribution
Domestic distribution nationwide.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI 00813502011647 Software version 1.1 - 3.17.1

Other devices under the same FDA submission

15 devices cleared under P170011, P140003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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