FDA Device recall Z-1376-2019
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- FDA Device
- Class I
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class I recall of Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 by Terumo Medical, citing 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 surfac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1376-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-04-26 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Terumo Medical |
| Distribution | US |
Product
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
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.
Identifiers
| code_info | Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Terumo Medical
- GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical - Terumo Needle, 30G x 1/2", Product Code NN3013R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1376-2019%22
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