International safety notice

Alert 2699 (Technovigilance) - St. Jude Medical Brasil LTDA - CentriMag - Possibility of damage to the connection cable between the motor and the console with consequent interruption of active support.

Brazil / Anvisa · BRA · Oct 11, 2018

Key facts

Title Alert 2699 (Technovigilance) - St. Jude Medical Brasil LTDA - CentriMag - Possibility of damage to the connection cable between the motor and the console with consequent interruption of active support.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: CentriMag Technical Name: Extracorporeal Circulation System ANVISA registration number: 10332340425 Risk Class: III Affected model: 201-10002 Affected serial numbers: L01229-0001;
Manufacturer EMPRESA DETENTORA DO REGISTRO ST JUDE MEDICAL BRASIL LTDA CNPJ 00986846000142 RUA ITAPEVA 538 5º AO 8º ANDARES SÃO PAULO SÃO PAULO TEL 11 5080 5454 EMAIL ROBERTAPETROCINOABBOTCOM FABRICANTE DO PRODUTO THORATHEC SWITZERLAND GMBH TECHNOPARKSTRASSE 1 ZH 8005 ZURICH SUÍÇA
Models L01475-0003, L02209-0002, L02209-0003, L01963-0016, L06081-0012, L01661-0023, L01591-0009, L04536-0021, L01475-0004, L06081-0010, L05215-0017, L01475-0007 and 40 more
Date Oct 11, 2018
Regulator page anvisa.gov.br

At a glance

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