International safety notice
Alert 2885 (Technovigilance) - Medtronic Comercial Ltda - Heartware - Ventricular Assistance System Possibility that the MAC adapter may be damaged when connected to a 220V AC or higher electrical outlet.
Brazil / Anvisa · BRA · May 21, 2019
Key facts
| Title | Alert 2885 (Technovigilance) - Medtronic Comercial Ltda - Heartware - Ventricular Assistance System Possibility that the MAC adapter may be damaged when connected to a 220V AC or higher electrical outlet. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Heartware - Ventricular Assistance System Technical Name: Intracardiac Pump ANVISA registration number: 10339190685 Risk Class: IV Affected model: All components that are part of the Heartware Ventricular Assist System Affected serial numbers: MON100310, MON100381, MAC000997. |
| 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 HEARTWARE INC 14400 NW 60TH AVEMMIAMI LAKES FL 33014 ESTADOS UNIDOS |
| Models | MON100310, MON100381, MAC000997, 10339190685 |
| Date | May 21, 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