International safety notice
Intra-Aortic Balloon Pump System: Intra-Aortic Balloon Pump
Brazil / Anvisa · BRA · Aug 15, 2017
Key facts
| Title | Intra-Aortic Balloon Pump System: Intra-Aortic Balloon Pump |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Intra-Aortic Balloon Pump Technical name: Intra-Aortic Balloon Pump System ANVISA registration number: 10390690062 Risk class: III Affected model: CS100 intra-aortic balloon pump; Affected serial numbers: All units distributed between March 24, 2003 and December 11, 2013. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA CNPJ 00944324000188 AV MARGINAL DO RIBEIRÃO DOS CRISTAIS 500 CAJAMAR SP FABRICANTE DATASCOPE CORP 1300 MACARTHUR BLVD MAHWAH NJ USA 07430 ESTADOS UNIDOS DA AMÉRICA TELEFONE 19737097652 EMAIL KARENLEFEVEREGETINGECOM |
| Models | 10390690062, CS300, CS100 |
| Date | Aug 15, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 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