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.
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.
The catheter's outer balloon may not deflate correctly during use, which can cause problems at the insertion site after the procedure. This could lead to complications like bleeding or infection at the puncture site.
Medical professionals who use the FLASH Ostial System catheters for angioplasty procedures are most at risk. Patients who have received this catheter during treatment may also be affected.
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.
Look for the reference number OAB6014BA and lot number 82210399 on the catheter packaging or documentation.
The recall is due to a manufacturing issue that may cause the outer balloon to not deflate properly, increasing the risk of access site complications.
Check the product reference number and lot number on the packaging. If it matches OAB6014BA and lot 82210399, contact Ostial Corporation for further instructions.
The recall states there is a potential for increased risk of access site complications, but the remedy does not specify immediate stop-use or serious injury risk.
We’ve drafted a message you can send Ostial to request your refund or repair — edit it as you like.
Subject: Recall Z-2309-2021 — Ostial Ostial Hello, I own a Ostial that is covered by recall Z-2309-2021 from Ostial. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
