Date Initiated by Firm | December 18, 2009 |
Date Posted | March 11, 2010 |
Recall Status1 |
Terminated 3 on March 29, 2012 |
Recall Number | Z-1101-2010 |
Recall Event ID |
54369 |
510(K)Number | K072313 |
Product Classification |
vascular introducer - 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 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 |
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 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 = DQY
|