Microvention Bobby Balloon Guide Catheter Recall: Balloon Pinhole Defects
Microvention recalls Bobby Balloon Guide Catheters with serial numbers BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095 due to increased balloon pinhole defects.
Lower-risk recall
Due to an increase rate of balloon pinhole defects.
What happened, in plain English
Microvention is recalling certain Bobby Balloon Guide Catheters because they have a higher rate of balloon pinhole defects. This could lead to potential complications during medical procedures. Read more at govinfonow.com/recall/459852-microvention-bobby-balloon-guide-catheter-recall-balloon-pinhole-defects.
Source Summary by GovInfoNow · govinfonow.com/recall/459852-microvention-bobby-balloon-guide-catheter-recall-balloon-pinhole-defects · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2912-2026
Cite this page
“Microvention Bobby Balloon Guide Catheter Recall: Balloon Pinhole Defects.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459852-microvention-bobby-balloon-guide-catheter-recall-balloon-pinhole-defects. Based on FDA recall #Z-2912-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2912-2026%22&limit=1).
Why it’s dangerous
The catheter balloons may develop pinholes, which could allow blood to leak into the bloodstream during medical procedures. This might cause complications like infections or bleeding.
Who’s affected
Healthcare professionals using Microvention's Bobby Balloon Guide Catheters with specific model numbers and lot codes listed in the recall notice. Patients using these catheters during procedures are at risk if the device fails.
How to tell if you have this one
Check for model numbers: BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, or MV-BGA01095. Also, verify the lot numbers listed in the recall notice.
- Brand
Microvention- Product
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in- Category
Medical device
What to do — step by step
Check Product Details
Look for the model numbers and lot numbers listed in the recall notice to determine if your catheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 26 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, New Hampshire, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2912-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2912-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.