Terumo Medical Corporation: Medical Device Recall in 2019 - (Recall #: Z-1375-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 26, 2019

Date Posted: June 5, 2019

Recall Number: Z-1375-2019

Event ID: 82705

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1431

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.

Voluntary or Mandated:

Voluntary: Firm initiated