International safety notice

Alert 2641 (Technovigilance) - Medtronic Comercial Ltda - Paradigm Medtronic External Insulin Infusion Pump / Paradigm Veo External Insulin Infusion Pump - Possibility of vulnerability in the remote control.

Brazil / Anvisa · BRA · Aug 10, 2018

Key facts

Title Alert 2641 (Technovigilance) - Medtronic Comercial Ltda - Paradigm Medtronic External Insulin Infusion Pump / Paradigm Veo External Insulin Infusion Pump - Possibility of vulnerability in the remote control.
Regulator Brazil / Anvisa
Country BRA
Brand Trade Name: Paradigm Medtronic External Insulin Infusion Pump / Paradigm Veo External Insulin Infusion Pump Technical Name: Infusion Pump ANVISA registration number: 10339190274; Risk Class: III Modelo afetado: MMT-515; MMT-515NAB; MMT-515NAL; MMT-515NAP; MMT-515NAS; MMT-715; MMT-715NAB; MMT-715NAL; MMT-715NAP; MMT-715NAS; MMT-522; MMT-722; MMT -554DEH; MMT -554DEL; MMT -554DEP; MMT -554DES; MMT -754DEB; MMT -754DEH; MMT -754DEL; MMT -754DEP; MMT -754DES; MMT-554; MMT-754 Affected serial numbers: CMR423575H;
Manufacturer EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOM NATALIAJMAIAMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE ESTADOS UNIDOS
Models CMR416606H, MMT-715NAL, CMR372794H, 754DEH, MMT-715NAB, MMT-515NAL, 754DES, MMT-522, MMT-722, MMT-715NAS, MMT-515NAP, CMR416540H and 21 more
Date Aug 10, 2018
Regulator page anvisa.gov.br

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  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

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