Urgent Field Safety Notice For Introducer Kit For Impella By Oscor, Inc

Recall Summary Oscor, Inc is issuing an urgent field safety notice for the Introducer Kit for Impella, which has been distributed in Germany and the EU. This is a Class I recall, indicating a serious problem with the device. The specific reason for the recall is not detailed in the provided information.

Recalling firm

Oscor, Inc

Product

Introducer Kit for Impella

Reason

Urgent Field Safety Notice for Introducer Kit for Impella by Oscor, Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-07-16

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/ccbf5f6a-0af3-413f-a7df-0715eade4760