Urgent Field Safety Notice For Cre Wireguided Balloon Dilatation Catheter By Boston Scientific Corporation Marlborough

Recall Summary Boston Scientific Corporation is recalling CRE Wireguided Balloon Dilatation Catheters distributed in Germany and the EU due to a safety issue that requires immediate corrective action. This is a Class I recall, the most serious classification. The recall affects medical devices used in balloon dilatation procedures, and healthcare facilities in affected regions should take note of this urgent notice.

Recalling firm

Urgent Field Safety Notice for CRE Wireguided Balloon Dilatation Catheter by Boston Scientific Corporation Marlborough ,

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for CRE Wireguided Balloon Dilatation Catheter by Boston Scientific Corporation Marlborough 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for CRE Wireguided Balloon Dilatation Catheter by Boston Scientific Corporation Marlborough 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-26

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/b8d67dd9-fad6-4416-92d2-e9ae145bc1b4