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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 Recall
InterValve V8 Balloon Aortic Valvuloplasty Catheter
see related information
Date Posted May 15, 2014
Recall Status1 Terminated on June 16, 2014
Recall Number Z-1621-2014
Recall Event ID 67964
Premarket Notification
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, Minnesota 55345
Manufacturer Reason
for Recall
Leak issues were discovered through accelerated age testing.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OZT and Original Applicant = INTERVALVE, INC
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