International safety notice

Technical Name: Catheters

Brazil / Anvisa · BRA · Mar 30, 2016

Key facts

Title Technical Name: Catheters
Regulator Brazil / Anvisa
Country BRA
Brand Commercial name: INTRA AORTIC BALLOON CATHETER (IAB) ARROW REDIGUARD ## ANVISA registration number: 80004970004 ## Risk class: IV ## Affected model(s): IAB-S730C ## Lot(s) / No. of affected series(s): 18F15D0028 18F15F0027 18F15F0037 18F15G0003 18F15G0011 18F15G0032 18F15H0046 18F15M0009.
Manufacturer DADOS DO DETENTOR DO REGISTRO NO BRASIL ISOMEDICAL COMERCIAL CNPJ 00757668000188 ENDEREÇO R GUILHOBEL 41 VILA MONTE ALEGRE SÃO PAULOSP DADOS DO FABRICANTE ARROW INTERNATIONAL INC 9 PLYMOUTH STREET EVERETTMA 02149
Models 18F15D0028, 18F15G0011, 18F15F0027, 18F15F0037, IAB-S730C, 18F15H0046, 18F15G0032, 18F15G0003, 18F15M0009, 80004970004
Date Mar 30, 2016
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 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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