International safety notice
Technical Name: PHARMACOLOGICAL STENT FOR CORONARY ARTERIES
Brazil / Anvisa · BRA · Apr 12, 2016
Key facts
| Title | Technical Name: PHARMACOLOGICAL STENT FOR CORONARY ARTERIES |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: BIOMATRIX FLEX CORONARY STENT SYSTEM WITH DRUG ELUTION - Registration: 80102510990 - Risk Class: IV (Maximum Risk) - Affected Models: BMX3511;BMX3518;BMX3524;BMX4018;BMX4024 - Affected Lots: 35 UNITS OF BMX CODE- 4018 LOT K15100017 NOT SOLD |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NO BRASIL VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA CNPJ 04718143000194 RUA BATATAES 391 CONJS 11 13 SÃO PAULOSP CRISTIANEAGUIRREVRMEDICALCOMBR FABRICANTE BIOSENSORS EUROPE AS RUE DE LAUSANNE 29 CH MORGES SUIÇA FIELSDAFETYNOTICEBIOSENSORSCOM |
| Models | BMX3518, BMX-4018, BMX4018, BMX3511, 80102510990, K15100017, BMX4024, BMX3524 |
| Date | Apr 12, 2016 |
| 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