Z-2309-2021Class II

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Name: Z-2309-2021 FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Creator: Ostial Corporation
Published: 2021-07-14
License: https://open.fda.gov/license/

Verge Medical Inc. / initiated 2021-07-14 / Terminated / root cause: manufacturing process

FDA source

Ostial Corporation began a recall of FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA on 2021-07-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2309-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-14
Posted: 2021-08-17
Terminated: 2024-01-30
Recalling firm: Verge Medical Inc.
Product: FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: Lot: 82210399

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2309-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2309-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-17

Product code LIT

K122379Class IIFlash Pta Balloon Dilatation Catheter - 4Mm X 14Mm X 135Cm, Flash Pta Balloon Dilatation Catheter - 4Mm X 19Mm X 135CmOstial Corporation / cleared 2012-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)