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U.S. Department of Health and Human Services

Class 2 Device Recall FLASH Ostial System

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 Class 2 Device Recall FLASH Ostial Systemsee related information
Date Initiated by FirmJuly 14, 2021
Create DateAugust 17, 2021
Recall Status1 Terminated 3 on January 30, 2024
Recall NumberZ-2309-2021
Recall Event ID 88334
510(K)NumberK122379 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductFLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Code Information Lot: 82210399
FEI Number 3008700817
Recalling Firm/
Manufacturer		 Ostial Corporation
197 E Hamilton Ave Ste 101
Campbell CA 95008-0261
For Additional Information Contact
408-541-1007
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce40
DistributionUS Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LIT
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