Skip to content
Recall Observatory FDA recall evidence

Device product

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Z-1376-2019

April 26, 2019

Class I

Product summary

Firm
Terumo Medical Corporation
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

    reason.no_named_rule · v1.0.0

    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.