Terumo Medical Corporation: Medical Device Recall in 2019 - (Recall #: Z-1376-2019)

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:

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

Product Classification:

Class I

Date Initiated: April 26, 2019

Date Posted: June 5, 2019

Recall Number: Z-1376-2019

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: 1481

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.

Voluntary or Mandated:

Voluntary: Firm initiated