Abiomed Inc.

Warning LetterOpen

Andrew Greenfield President Abiomed Inc. 22 Cherry Hill Drive Danvers , MA 01923 United StatesFEI 1220648Issued Sep 19, 2023Division of Medical Device and Radiological Health Operations East

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Letter Details

Firm: Abiomed Inc.
Location: Andrew Greenfield President Abiomed Inc. 22 Cherry Hill Drive Danvers , MA 01923 United States
FEI Number: 1220648
Country: United States
Issue Date: September 19, 2023
Issuing Office: Division of Medical Device and Radiological Health Operations East
Product Type: Medical Devices
Status: Open

Summary

Abiomed Inc. was cited for manufacturing the Impella Pump devices and the Impella Connect System without proper regulatory authorization, with the latter found to be adulterated under federal law for lacking an approved premarket approval (PMA) application or investigational device exemption. The FDA inspection conducted from March through April 2023 at the company's Danvers, Massachusetts facility identified multiple compliance failures related to Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) requirements, which the company subsequently responded to across four separate submissions. The Impella Connect System, comprising web-based software and hardware components designed to work with the Automated Impella Controller, was specifically flagged as a device marketed without required FDA approval.