International safety notice
Alert 2596 (Technosurveillance): Update - St. Jude Medical Brasil LTDA - HeartMate 3 Left Ventricular Assist System - Outflow occlusions due to graft torsion may result in a persistent low flow alarm.
Brazil / Anvisa · BRA · Jun 27, 2018
Key facts
| Title | Alert 2596 (Technosurveillance): Update - St. Jude Medical Brasil LTDA - HeartMate 3 Left Ventricular Assist System - Outflow occlusions due to graft torsion may result in a persistent low flow alarm. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: HeartMate 3 Left Ventricular Assist System Technical Name: Other Cardiovascular Implants ANVISA registration number: 10332340428 Risk Class: IV Affected model: HeartMate 3 Affected serial numbers: Model: 10010167 - Serial numbers: MLP-009201; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ST JUDE MEDICAL BRASIL LTDA CNPJ 00986846000142 RUA ITAPEVA 538 5º AO 8º ANDARES SÃO PAULO SP TEL 55115080 EMAIL MARCOSANTOSABBOTTCOM FABRICANTE DO PRODUTO THORATEC CORPORATION 6035 STONERIDGE DRIVE PLEASANTON CA 94588 EUA ESTADOS UNIDOS DA AMÉRICA |
| Models | MLP-009205, 10010167, MLP-009201, MLP-009207, MLP-009203, MLP-009667, 10332340428, MLP-009206 |
| Date | Jun 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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