International safety notice
Alert 2614 (Technosurveillance) - Medtronic Comercial Ltda - Microtargeting Star Drive Possibility of damage to the conductor and probe when the depth stop screw is excessively tightened on the conductor.
Brazil / Anvisa · BRA · Jul 13, 2018
Key facts
| Title | Alert 2614 (Technosurveillance) - Medtronic Comercial Ltda - Microtargeting Star Drive Possibility of damage to the conductor and probe when the depth stop screw is excessively tightened on the conductor. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Microtargeting Star Drive Technical Name: Neurosurgery Device ANVISA registration number: 10339190550 Risk Class: I Affected model: FC8001, FC8003, FC8004, FC8005, FC8006, FC8008, FC8010, FC8011 Affected serial numbers: 31832; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEDTRONIC COMERCIAL LTDA CNPJ 01772798000152 AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOM NATALIAJMAIAMEDTRONICCOM FABRICANTE DO PRODUTO FHC INC 1201 MAIN STREET BOWDOIN MAINE 04287 ESTADOS UNIDOS |
| Models | 34600, 31773, 31811, 26700, FC8011, FC8008, FC8003, 31818, 34853, 34595, 34620, FC8010 and 10 more |
| Date | Jul 13, 2018 |
| 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