Boston Scientific recalls Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit

Recall date

March 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1729-2020

FDA classification

Class II

Brand / firm

Boston Scientific

Sold / distributed

Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan

Why it was recalled

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit