Z-0636-2024Class II

Impella Connect, software portal for online device management that allows clinicians and Impella support...

Name: Z-0636-2024 Impella Connect, software portal for online device management that allows clinicians and Impella support...
Creator: Abiomed, Inc.
Published: 2023-12-06
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-12-06 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data on 2023-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0636-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-06
Posted: 2024-01-04
Recalling firm: Abiomed, Inc.
Product: Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Product code: PYX Temporary Non-Roller Type Right Heart Support Blood Pump
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
FDA root cause: No Marketing Application
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.
Quantity in commerce: n/a - no physical product
Distribution: Domestic distribution nationwide.
Product codes and lots: UDI-DI 00813502011647 Software version 1.1 - 3.17.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0636-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04

Product code PYX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)