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U.S. Department of Health and Human Services

Class 2 Device Recall Amplatzer TorqVue Delivery System

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 Class 2 Device Recall Amplatzer TorqVue Delivery Systemsee related information
Date Initiated by FirmDecember 18, 2009
Date PostedMarch 11, 2010
Recall Status1 Terminated 3 on March 29, 2012
Recall NumberZ-1101-2010
Recall Event ID 54369
510(K)NumberK072313 
Product Classification vascular introducer - Product Code DQY
ProductAGA 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
FEI Number 3005334138
Recalling Firm/
Manufacturer		 AGA Medical Corporation
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact
763-513-9227
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		Process design
ActionAn 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 Commerce57
DistributionWorldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.
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 = DQY
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