FDA Medical Device Recalls (openFDA)
Ostial Corporation: FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
- Recall number
- Z-2309-2021
- Recalling firm
- Ostial Corporation
- Product
- FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
- Status
- Terminated
- Initiated
- 2021-07-14
- Posted
- not on file
- Terminated
- 2024-01-30
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 07/14/2021, recall notices were mailed to customers. Customers were asked to take the following actions: 1) Immediately examine your inventory and quarantine product subject to recall. 2) Return all unused inventory to the recalling firm. Please contact Customer Service at 844 352-7411. 3) Please complete the enclosed Customer Acknowledgement Form and submit to Quality@ostialflash.com. 4) Please forward a copy of this notification to those within your organization that need to be aware. Customers with additional questions or concerns are encouraged to contact Customer Service at 844-352-7411 Monday-Friday/8am-4pm PST or contact your local Field Representative.
- Quantity
- 40
- Distribution
- US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
- Lot, serial or model codes
- Lot: 82210399
- 510(k) numbers
- ["K122379"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3008700817
- Firm city
- Campbell
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28