Portico Solo Re-Collapsible Access System — Class I medical device recall Z-1376-2019
Terminated recall by Terumo Medical Corporation, reported 2019-06-05, distributed nationwide. There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of
| Recall number | Z-1376-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corporation, Elkton, MD, United States |
| Recall initiated | 2019-04-26 |
| Classified | 2019-05-28 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, HK, PE, PT, SG |
| Quantity | 1,481 |
| Lot numbers | VG05, VG09, VG21, VG29, VH28, VK09, VK18, VL25, VM11, VM20, VN08, VN17, VN27, VP07, WM03, WM17, WM31 |
| Model numbers | PRTSOLO-19, PRTSOLO-20 |
Product
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1376-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.