Boston Scientific Corporation recalls Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340

Recall date

June 1, 2017

Source

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

Recall number

Z-2674-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

MI, MO Foreign: Austria France Great Britain Italy Spain Sweden

Why it was recalled

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

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

What was recalled

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340