Device product
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Z-1376-2019
Product summary
- Event
- Event 82705
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1481
- Official record key
device-enforcement:Z-1376-2019
Official wording
Reason: There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Code information: Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
Distribution pattern: The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
Derived failure modes
-
Unknown
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.