Urgent Field Safety Notice For Faradrive Steerable Sheath Clear By Boston Scientific Corporation Marlborough

Recall Summary Boston Scientific Corporation is issuing an urgent safety notice for FARADRIVE Steerable Sheath Clear devices. The devices are classified as a Class I recall, the most serious category, though the specific safety issue is not clearly stated in the available information. The affected devices were distributed in Germany and the EU.

Recalling firm

Urgent Field Safety Notice for FARADRIVE Steerable Sheath Clear by Boston Scientific Corporation Marlborough , Download_

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for FARADRIVE Steerable Sheath Clear by Boston Scientific Corporation Marlborough 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for FARADRIVE Steerable Sheath Clear by Boston Scientific Corporation Marlborough 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-06-12

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/b03d0103-439a-43d5-876f-2ab25efb1c6d