International safety notice
Alert 2546 Updated (Technosurveillance) - St. Jude Medical - HeartMate 3 Left Ventricular Assistance System Guidance for doctors regarding the possibility of serious adverse events in patients.
Brazil / Anvisa · BRA · Apr 17, 2018
Key facts
| Title | Alert 2546 Updated (Technosurveillance) - St. Jude Medical - HeartMate 3 Left Ventricular Assistance System Guidance for doctors regarding the possibility of serious adverse events in patients. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: HeartMate 3 Left Ventricular Assist System. Technical name: Other Cardiovascular Implants. ANVISA registration number: 10332340428. Product type: Material. Risk class: IV. Affected model: HeartMate 3. Affected serial numbers: Model: 10010167 - Serial numbers: MLP-009201; Alert Update: inclusion, as attachments, of Alert Messages sent to customers after the publication of Alert 2546. Access the full content of Alert 2546 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ST JUDE MEDICAL BRASIL LTDA CNPJ 00986846000142 RUA ITAPEVA 538 5º AO 8º ANDARES SÃO PAULO SP TEL 11 55115080 EMAIL MARCOSANTOSABBOTTCOM FABRICANTE DO PRODUTO THORATEC CORPORATION 6035 STONERIDGE DRIVE PLEASANTON CA 94588 EUA TELEFONE 925 8478600 FAX 925 8478574 EMAIL LETICIASERRANOABBOTTCOM |
| Models | MLP-009203, MLP-009206, 10010167, MLP-009205, MLP-009667, MLP-009201, 10332340428, MLP-009207 |
| Date | Apr 17, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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