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Recall Observatory FDA recall evidence

Device product

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

Z-2309-2021

July 14, 2021

Class II

Product summary

Firm
Ostial Corporation
Event
Event 88334
Status
Terminated
Classification
Class II
Quantity
40
Official record key
device-enforcement:Z-2309-2021

Official wording

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.

Code information: Lot: 82210399

Distribution pattern: US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.