International safety notice
Catheters.
Brazil / Anvisa · BRA · Nov 20, 2015
Key facts
| Title | Catheters. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product: AMPHIRION DEEP OTW - DILATION CATHETER FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). AMD020040152 AMD025080152 AMD030080152 AMD035150152 AMD225210002 AMD020080002 AMD025120002 AMD030120002 AMD040040152 AMD225210152 AMD020080152 AMD025120152 AMD030120152 AMD040080002 AMD253210002 AMD020120002 AMD025150002 AMD030150002 AMD040080152 AMD253210152. #### UPDATE (01/14/2016): According to the company, all the codes of the affected products were incorrectly reported globally, but in Brazil only one code was affected (AMD225210152), of which only 03 batches are at risk - 209532760, 209507756 and 209507757. The previous list (see above) therefore does not apply in its entirety to Brazil. |
| Manufacturer | DETENTOR DE REGISTRO MEDTRONIC COMERCIAL LTDACNPJ 01772798000152 FABRICANTE INVATEC SPA ITÁLIA |
| Models | AMD020080002, 209532760, AMD020040152, 209507757, AMD030120002, AMD225210002, 10339190532, AMD025150002, AMD030080152, AMD030080002, AMD040040152, AMD040150002 and 36 more |
| Date | Nov 20, 2015 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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