FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1101-2010
- Recalling firm
- AGA Medical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2009-12-18
- Posted
- 2010-03-11
- Terminated
- 2012-03-29
- 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.
- Lot, serial or model codes
- Lot 0906151781
- 510(k) numbers
- ["K072313"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28