FDA-Device2017-07-12Class II
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Boston Scientific Corporation
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
Sold states
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Affected count
32 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2674-2017Don't want to check this manually?
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