The Recall Desk
HighFDA (Devices)·Z-2309-2021·Announced 2021-08-25

Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty

Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall without reported illnesses or hospitalizations. The hazard is a manufacturing defect creating risk of harm (access site complications) without documented injury, meeting the High severity criterion.

Plain-English summary

The FLASH Ostial System, a dual balloon angioplasty catheter (model REF: OAB6014BA), is being recalled by Ostial Corporation due to a manufacturing defect.

The catheter has a manufacturing issue that can result in difficulty deflating the outer balloon. This malfunction may increase the risk of access site complications during or after the procedure.

Approximately 40 units of the affected lot (Lot 82210399) were distributed nationwide across 17 states including Arizona, Michigan, Ohio, Indiana, Kentucky, Montana, Florida, Pennsylvania, Georgia, Minnesota, Kansas, New York, Illinois, South Dakota, Louisiana, South Carolina, and Connecticut.

If you have received this product, contact Ostial Corporation for guidance on handling the affected units.

The recalled product

Product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Manufacturer
Ostial Corporation
Category
Medical Device — Angioplasty Equipment
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 82210399

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Related recalls

Same hazard · manufacturing defect

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