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U.S. Department of Health and Human Services

Class 2 Device Recall InterValve V8 Balloon Aortic Valvuloplasty Catheter

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  Class 2 Device Recall InterValve V8 Balloon Aortic Valvuloplasty Catheter see related information
Date Initiated by Firm March 14, 2014
Date Posting Updated May 15, 2014
Recall Status1 Terminated 3 on June 16, 2014
Recall Number Z-1621-2014
Recall Event ID 67964
510(K)Number K133607  
Product Classification Balloon aortic valvuloplasty - Product Code OZT
Product InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Code Information Lot numbers: 101637, 101640
Recalling Firm/
Manufacturer
InterValve Inc
16200 State Highway 7
Unit B
Minnetonka MN 55345
Manufacturer Reason
for Recall
Leak issues were discovered through accelerated age testing.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Since this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest.
Quantity in Commerce 2
Distribution Distribution to TN only
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OZT and Original Applicant = INTERVALVE, INC
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