Device product
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Z-0970-2017
Product summary
- Event
- Event 75875
- Status
- Terminated
- Classification
- Class I
- Quantity
- 101
- Official record key
device-enforcement:Z-0970-2017
Official wording
Reason: Complaints of sheath separation, kinking, and/or tip damage during use.
Code information: Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27
Distribution pattern: Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Derived failure modes
-
Unknown
Complaints of sheath separation, kinking, and/or tip damage during use.