Skip to content
Recall Observatory FDA recall evidence

Device product

SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

Z-1375-2019

April 26, 2019

Class I

Product summary

Firm
Terumo Medical Corporation
Event
Event 82705
Status
Terminated
Classification
Class I
Quantity
1431
Official record key
device-enforcement:Z-1375-2019

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:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09

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.