Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.
Enforcement
- Recall Number
- Z-3227-2017
- Event ID
- 78127
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Vascular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 4, 2017
- Initiation Date
- September 13, 2017
- Classification Date
- September 27, 2017
- Termination Date
- May 18, 2020
- Address
- 3576 Unocal Pl, N/A, Santa Rosa, CA, 95403-1774, United States
Description
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.
It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157
US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
20 units