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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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