Device product
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.
Z-3227-2017
Product summary
- Event
- Event 78127
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-3227-2017
Official wording
Reason: 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.
Code information: UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157
Distribution pattern: US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
Derived failure modes
-
Unknown
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.