Urgent Field Safety Notice For Sphere-360 Catheter By Medtronic Inc

Recall Summary Medtronic Inc is issuing an urgent field safety notice for the Sphere-360 Catheter, a Class I recall affecting devices distributed in Germany and the EU. The recall notice does not specify the underlying safety issue in the provided information. Patients and healthcare providers in the affected regions who use this device should contact Medtronic for details about the specific concern and next steps.

Recalling firm

Medtronic Inc

Product

Sphere-360 Catheter

Reason

Urgent Field Safety Notice for Sphere-360 Catheter by Medtronic Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-07-27

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/99e969b5-dc2d-40f3-b951-22b68669c357