• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Amplatzer TorqVue Delivery System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Amplatzer TorqVue Delivery System
see related information
Date Posted March 11, 2010
Recall Status1 Terminated on March 29, 2012
Recall Number Z-1101-2010
Recall Event ID 54369
Premarket Notification
510(K) Number
K072313 
Product Classification Catheter, Percutaneous - Product Code DQY
Product AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.
Code Information Lot 0906151781
Recalling Firm/
Manufacturer
AGA Medical Corporation
5050 Nathan Ln N
Plymouth, Minnesota 55442-3209
Manufacturer Reason
for Recall
In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.
FDA Determined
Cause 2
DESIGN: Process Design
Action An AGA Medical Product Recall Notice, dated December 18, 2009 was sent to customers on 12/18/2009. The letter identified the affected product, described the issue and asked for devices to be returned. Customers are asked to complete a form attached to the product recall notice and return it to AGA via fax or email.
Quantity in Commerce 57
Distribution Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.
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 = DQY and Original Applicant = AGA MEDICAL CORP.
-
-