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MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in fac
Recalled August 19, 2026 · FDA recall Z-2912-2026 · MICROVENTION
Hazard
Due to an increase rate of balloon pinhole defects. · FDA Class II
Units
5500 devices
Sold at
Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.
Description
Due to an increase rate of balloon pinhole defects.
Product
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
Manufacturer(s)
MICROVENTION INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →