International safety notice
Alert 2692 (Technosurveillance) - Maquet - Intra-Aortic Balloon Pump - Cardiosave, at altitudes above 975 m, may not successfully complete the automatic filling process necessary to start pumping.
Brazil / Anvisa · BRA · Oct 8, 2018
Key facts
| Title | Alert 2692 (Technosurveillance) - Maquet - Intra-Aortic Balloon Pump - Cardiosave, at altitudes above 975 m, may not successfully complete the automatic filling process necessary to start pumping. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Intra-Aortic Balloon Pump Technical Name: Balao Intra-Aortic Pump System ANVISA registration number: 10390690062 Risk Class: III Affected model: Cardiosave Affected serial numbers: CH207880C5; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA CNPJ 00944324000188 AV MARGINAL DO RIBEIRÃO DOS CRISTAIS 500 CAJAMAR SP TEL 1126087387 EMAIL GUILHERMEPACINIGETINGECOM FABRICANTE DO PRODUTO DATASCOPE CORP 1300 MACARTHUR BLVD MAHWAH NJ 07430 ESTADOS UNIDOS DA AMÉRICA |
| Models | CH245699K6, 10390690062, CH207880C5 |
| Date | Oct 8, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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