Urgent Field Safety Notice For Merit Splashwire Hydrophilic Steerable Guide Wire By Merit Medical Systems Inc.

Recall Summary Merit Medical Systems is recalling Merit SplashWire Hydrophilic Steerable Guide Wires distributed in Germany and the EU due to an unspecified safety concern. This is a Class I recall, the most serious classification. The recall affects medical devices used in medical procedures, and Merit Medical Systems has issued urgent corrective actions for healthcare facilities using these products.

Recalling firm

Urgent Field Safety Notice for Merit SplashWire Hydrophilic Steerable Guide Wire by Merit Medical Systems Inc. , Downloa

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Merit SplashWire Hydrophilic Steerable Guide Wire by Merit Medical Systems Inc

Reason

assessment Field corrective actions Urgent Field Safety Notice for Merit SplashWire Hydrophilic Steerable Guide Wire by Merit Medical Systems Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-04-30

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/07c74125-7188-4d4f-a906-0f958cae3a46