Date Initiated by Firm |
March 14, 2014 |
Date Posted |
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
|