AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the int
FDA device recall Z-1101-2010 · posted 2010-03-11 · Terminated
Recall details
- Recalling firm
- AGA Medical Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 57
- Distribution
- Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.
- Date initiated
- 2009-12-18
- Date posted
- 2010-03-11
- Date terminated
- 2012-03-29
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZER TORQVUE DELIVERY SYSTEM (K072313) | Aga Medical Corp. | 2007-11-02 |