International safety notice

Catheters

Brazil / Anvisa · BRA · Jul 13, 2017

Key facts

Title Catheters
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Euphora Balloon Catheter Technical name: Catheters ANVISA registration number: 10339190628 Risk class: IV Modelo afetado: EUP1506X, EUP2015X, EUP22520X, EUP2530X, EUP3010X, EUP32512X, EUP3520X, EUP37525X, EUP1510X, EUP2020X, EUP22525X, EUP27506X, EUP3012X, EUP32515X, EUP3525X, EUP4006X, EUP1512X, EUP2025X, EUP2506X, EUP27510X, EUP3015X, EUP32520X, EUP3530X, EUP4010X, EUP1515X, EUP2030X, EUP2510X, EUP27512X, EUP3020X, EUP32525X, EUP37506X, EUP4012X, EUP1520X, EUP22506X, EUP2512X, EUP27515X, EUP3025X, EUP3506X, EUP37510X, EUP4015X, EUP2006X, EUP22510X, EUP2515X, EUP27520X, EUP3030X, EUP3510X, EUP37512X, EUP4020X, EUP2010X, EUP4020X,EUP2010X, EUP22512X, EUP2520X, EUP27525X, EUP32506X, EUP3512X, EUP37515X,EUP4025X, EUP2012X EUP22515X EUP2525X, EUP3006X, EUP32510X, EUP3515X, EUP37520X, EUP4030X, SLC1506X, SLC2015X, SLC22520X, SLC2530X, SLC3015X, SLC3512X, SLC4012X, SLC1510X, SLC2020X, SLC22525X, SLC27512X, SLC3020X, SLC3515X, SLC4015X, SLC1512X, SLC2025X, SLC2506X, SLC27515X, SLC3025X, SLC3520X, SLC4020X, SLC1515X, SLC2030X, SLC2510X, SLC27520X, SLC3030X, SLC3530X, SLC4025X, SLC1520X, SLC22506X, SLC2512X, SLC27525X, SLC32512X, SLC37512X, SLC4030X, SLC2006X, SLC22510X, SLC2515X, SLC3006X, SLC32515X, SLC37515X, SLC2010X, SLC22512X, SLC2520X, SLC3010X, SLC3506X, SLC37520X, SLC2012X, SLC22515X, SLC2525X, SLC3012X, SLC3510X, SLC4010X. Affected serial numbers: 212553130 to 213283557
Manufacturer EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 TELEFONE 11 21829200 FABRICANTE FABRICANTE LEGAL MEDTRONIC INC 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 55432 ESTADOS UNIDOS FABRICANTE REAL MEDTRONIC MEXICO TIJUANA AVENIDA PASEO DE CUCAPAH 10510 CP 22210 PARQUE INDUSTRIAL EL LAGO TIJUANA MEXICO
Models SLC27515X, SLC37515X, SLC4015X, EUP2015X, SLC3030X, SLC1520X, SLC2012X, SLC1510X, EUP2506X, SLC2015X, EUP2020X, EUP4010X and 108 more
Date Jul 13, 2017
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 10–99 Matching device models in FDA data

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

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