Use cautionMedical device recall · FDA · Published July 14, 2021
Ostial FLASH System Dual Balloon Catheter Recall: Deflation Risk
Ostial recalls dual-balloon angioplasty catheters with potential deflation issues causing access site complications. Affected units include REF: OAB6014BA, Lot: 82210399.
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
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Contact the company
📍Recalling firmOstial Corporation197 E Hamilton Ave Ste 101 · Campbell, CA 95008-0261
✎ GovInfoNow plain-language explainer
Ostial Corporation is recalling its FLASH Ostial System dual-balloon angi:plasty catheters due to a manufacturing issue that might cause the outer balloon to not deflate properly. This could lead to complications at the insertion site after medical procedures. Read more at govinfonow.com/recall/62209-ostial-flash-system-dual-balloon-catheter-recall-deflation-risk.
“Ostial FLASH System Dual Balloon Catheter Recall: Deflation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62209-ostial-flash-system-dual-balloon-catheter-recall-deflation-risk. Based on FDA recall #Z-2309-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2309-2021%22&limit=1).
The FDA announced on July 14, 2021, that Ostial Corporation is recalling the FLASH Ostial System and Dual Balloon Angioplasty Catheter due to a manufacturing issue. The defect may cause difficulty deflating the outer balloon, increasing the risk of access site complications.
The angioplasty system has a manufacturing issue that may result in difficulty deflating the outer balloon. This defect may lead to an increased risk of access site complications.
Context
GovInfoNow's records show other recent recalls of similar products include Microvention Bobby Balloon Guide Catheter Recall: Balloon Pinhole Defects (2026-04-30), Boston Scientific Coyote Catheters: Inflation/Deflation Issues in Peripheral Vessels (2025-12-03), and LeMaitre TufTex Catheter Recall: Risk of Balloon Failure During Use (2026-08-28).
How to tell if you have this one
Check for the product reference number OAB6014BA and lot number 82210399 on the catheter packaging or documentation. The recall applies to the FLASH Ostial System dual-balloon angioplasty catheters sold by Ostial Corporation.
Brand
Ostial
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number OAB6014BA and lot number 82210399 on the catheter packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Montana, New York, Ohio, Pennsylvania, South Carolina, South Dakota.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2309-2021 (July 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2309-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.