FDA Device recall Z-2309-2021
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA by Ostial, citing 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 complica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2309-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-14 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ostial |
| Distribution | US |
Product
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Reason
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.
Identifiers
| code_info | Lot: 82210399 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2309-2021%22
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