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Class IIOngoing

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 fa

Recall date · record updated Aug 19, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
MICROVENTION INC.
Reason
Due to an increase rate of balloon pinhole defects.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98909…

Products

  1. 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.

    Codes/lots: 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)00842Quantity: 5500 devicesRecall no. Z-2912-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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