Recall Z-1101-2010 ยท DQY Catheter, Percutaneous
AGA Medical Corporation
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.
| Date | Mar 11, 2010 (initiated Dec 18, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 57 |
| Distribution | Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM Aga Medical Corp., Nov 2, 2007 |