FLASH Ostial System — Class II medical device recall Z-2309-2021
Terminated recall by Ostial Corporation, reported 2021-08-25, distributed nationwide. Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the oute
| Recall number | Z-2309-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ostial Corporation, Campbell, CA, United States |
| Recall initiated | 2021-07-14 |
| Classified | 2021-08-17 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2024-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| Lot numbers | 82210399 |
| Model numbers | OAB6014BA |
Product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2309-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.