FDA Medical Device Recalls (openFDA)
Terumo Medical Corporation: Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Recall number
- Z-1376-2019
- Recalling firm
- Terumo Medical Corporation
- Product
- Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Status
- Terminated
- Initiated
- 2019-04-26
- Posted
- 2019-05-28
- Terminated
- 2020-09-22
- 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.
- Root cause
- Device Design
- Action
- Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
- Quantity
- 1481
- Distribution
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
- Lot, serial or model codes
- Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
- 510(k) numbers
- ["K152498"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1118880
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28