FDA Medical devices recall ·
BOBBY Balloon Guide Catheter recall
- Recall number
- Z-2912-2026
- Date
- (initiated April 30, 2026)
- Company / brand
- Microvention Inc.
35 Enterprise, Aliso Viejo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5500 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to an increase rate of balloon pinhole defects.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 (01)00842429111062(11)250828(17)280731(10)0001226522 (01)00842429111062(11)250910(17)280831(10)0001264372 (01)00842429111062(11)250911(17)280831(10)0001281308 (01)00842429111062(11)250917(17)280831(10)0001283704 Lot Numbers: 0001218734 0001222844 0001224137 0001226522 0001264372 0001281308 0001283704 Catalog Number: BOB-895-EMEA UDI code: (01)00842429108550(11)241108(17)271031(10)0000756596 (01)00842429108550(11)241109(17)271031(10)0000757384 (01)00842429108550(11)241118(17)271031(10)0000758945 (01)00842429108550(11)241120(17)271031(10)0000765270 (01)00842429108550(11)241121(17)271031(10)0000767660 (01)00842429108550(11)241126(17)271031(10)0000772588 (01)00842429108550(11)241202(17)271130(10)0000774885 (01)00842429108550(11)241128(17)271031(10)0000778089 (01)00842429108550(11)241204(17)271130(10)0000779647 (01)00842429108550(11)241207(17)271130(10)0000781240 (01)00842429108550(11)241210(17)271130(10)0000784041 (01)00842429108550(11)241210(17)271130(10)0000799436 (01)00842429108550(11)241213(17)271130(10)0000802183 (01)00842429108550(11)241210(17)271130(10)0000802619 (01)00842429108550(11)241214(17)271130(10)0000809792 (01)00842429108550(11)241217(17)271130(10)0000812812 (01)00842429108550(11)241217(17)271130(10)0000814498 (01)00842429108550(11)241220(17)271130(10)0000816560 (01)0084
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.
States: Alabama Arkansas Arizona California Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Michigan Minnesota Missouri Montana North Carolina New Hampshire New Mexico New York Ohio Pennsylvania South Dakota Tennessee Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2912-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.