Z-3227-2017 Class II Terminated
FDA device recall Z-3227-2017 was initiated by Medtronic Vascular, Inc. on September 13, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 18, 2020). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- September 13, 2017
- Termination Date
- May 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product 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.
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
Code Information
UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157