BOBBY Balloon Guide Catheter
The BOBBY Balloon Guide Catheter has an increased rate of balloon pinhole defects.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
MicroVention Inc., of Aliso Viejo, California, recalled the BOBBY Balloon Guide Catheter due to an increased rate of balloon pinhole defects. The device is used to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
The company began the recall on April 30, 2026, and the FDA added it to the Enforcement Report on August 7, 2026.
Distribution was worldwide, including 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, and 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.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 40 of 104 lot codes shown.
BOBBY Balloon Guide Catheter
Product details from the notice
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.
- UDI-DI
- 00842429111062
- 0001218734
- 0001222844
- 0001224137
- 0001226522
- 0001264372
- 0001281308
- 0001283704
- Lot
- 0001218734
- 0001222844
- 0001224137
- 0001226522
- 0001264372
- 0001281308
- 0001283704
- 0000756596
- 0000784041
- 0000823532
- 0000912667
- 0000757384
- 0000799436
- 0000828250
- 0000915955
- 0000758945
- 0000802183
- 0000830529
- 0000919813
- 0000765270
- 0000802619
- 0000836906
- 0000922930
- 0000767660
- 0000809792
- 0000837785
- 0000927345
- 0000772588
- 0000812812
- 0000863256
- 0000930383
- 0000774885
- 0000814498
- 0000866698
- 0000937458
- 0000778089
- 0000816560
- 0000874138
- 0000945855
- 0000779647
Details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution in the states of 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, and Wisconsin. 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.
- Event ID
- 98909
- Recall No.
- Z-2912-2026
- Company
- MICROVENTION INC.Aliso Viejo, California
- Hazard
- Device defect
- Quantity recalled
- 5500 devices
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
