International safety notice
Alert 2920 (Technosurveillance) - Paradigm Medtronic External Insulin Infusion Pump - Paradigm Veo External Insulin Infusion Pump Possible cybersecurity risk.
Brazil / Anvisa · BRA · Jul 9, 2019
Key facts
| Title | Alert 2920 (Technosurveillance) - Paradigm Medtronic External Insulin Infusion Pump - Paradigm Veo External Insulin Infusion Pump Possible cybersecurity risk. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Paradigm Medtronic External Insulin Infusion Pump (registration 10339190274); Technical Name: Infusion Pump ANVISA registration number: 10339190274; Risk Class: III Modelo afetado: Registro 10339190274: MMT-515; MMT-515NAB; MMT-515NAL; MMT-515NAP; MMT-515NAS; MMT-715; MMT-715NAB; MMT-715NAL; MMT-715NAP; MMT-715NAS. Registro 10339190306: MMT-522; MMT-722. Registro 10339190464: MMT -554DEB; 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: See attachment "List of batch numbers at risk". |
| 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 FABIOLACAPPELLARIMEDTRONICCOM FABRICANTE DO PRODUTO MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE ESTADOS UNIDOS ESTADOS UNIDOS |
| Models | 10339190274, 554DEP, MMT-515NAL, 554DEL, 754DEL, MMT-515NAS, MMT-715, 554DES, MMT-754, MMT-522, 10339190464, MMT-515 and 15 more |
| Date | Jul 9, 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