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

Recall Summary Oscor, Inc. is issuing an urgent safety notice for the Introducer Kit for Impella devices distributed in Germany and the EU. The notice has been classified as Class I, indicating a serious issue with the product. The specific reason for the safety notice is not detailed in the information provided.

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/ec437a90-617f-4fe7-8c2d-94086de0536b