International safety notice
Alert 2883 (Technosurveillance) Terumo - Solopath Transfemoral - Solopath Ballon Expandable Transfemoral Introducer Possibility of loss of smooth transition from the tip surface to the external surface of the expandable sheath.
Brazil / Anvisa · BRA · May 20, 2019
Key facts
| Title | Alert 2883 (Technosurveillance) Terumo - Solopath Transfemoral - Solopath Ballon Expandable Transfemoral Introducer Possibility of loss of smooth transition from the tip surface to the external surface of the expandable sheath. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Solopath Ballon Expandable Transfemoral Introducer Technical Name: Introducers ANVISA registration number: 80012280193 Risk Class: II Affected model: STFI-1425; Affected serial numbers: All in-expiry lots: VH27, WG13, VG02, VA19, VD09, VA13, VK21. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TERUMO MEDICAL DO BRASIL LTDA CNPJ 03129105000133 PRAÇA GENERAL GENTIL FALCÃO 108 CJ 91 E 92 SÃO PAULO SP TEL 11 35943845 EMAIL RATERUMOCOMBR FABRICANTE DO PRODUTO TERUMO MEDICAL CORPORATION 950 ELKTON BLVD ELKTON MD 21921 EUA |
| Models | STFI-1925, STFI-2125, STFI-1935, STFI-1835, 80012280193, STFI-2135, STFI-1425, STFI-1625, STFI-1635, STFI-1825, STFI-1435 |
| Date | May 20, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1