Boston Scientific Corporation recalls Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300

Recalled July 12, 2017 · FDA recall Z-2673-2017 · Boston Scientific

Hazard

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 · FDA Class II

Units

39 units

Sold at

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

Description

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

Product

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →