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.
Due to an increase rate of balloon pinhole defects.
| Recalling firm | MICROVENTION INC. |
|---|---|
| Reason | Due to an increase rate of balloon pinhole defects. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Apr 30, 2026 |
| Region | CA, United States |
| Distribution | 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. |
| Quantity | 5500 devices |
| Code/Lot | Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)280731(10)0001224137 (0… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2912-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2912-2026)
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