International safety notice
Technical name: Other Cardiovascular Implants
Brazil / Anvisa · BRA · Dec 18, 2017
Key facts
| Title | Technical name: Other Cardiovascular Implants |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Heartware-Ventricular Assistance System Technical name: Other Cardiovascular Implants ANVISA registration number: 80583400001 Risk class: IV Affected model: No model. Affected serial numbers: BATTERY LT:1650,1650DE - BAT000001 to BAT039999; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ENDOTEC PRODUTOS MÉDICOS LTDA CNPJ 09586279000101 RUA SAMPAIO VIANA 202 CONJ 61 PARAISO SÃO PAULO SP FABRICANTE HEARTWARE INC 14400 NW 60 AVE MIAMI LAKES FL 33014 TELEFONE 508 7390950 FAX 508 7390948 |
| Models | BAT039999, 80583400001, BAT099999, BAT000001, BAT090000, 1650DE |
| Date | Dec 18, 2017 |
| 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