International safety notice
Alert 2736 (Technosurveillance) - Johnson & Johnson - ThermoCool SmartTouch SF Catheter - Carbonization formation at the ablation site.
Brazil / Anvisa · BRA · Nov 23, 2018
Key facts
| Title | Alert 2736 (Technosurveillance) - Johnson & Johnson - ThermoCool SmartTouch SF Catheter - Carbonization formation at the ablation site. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ThermoCool SmartTouch SF Catheter Technical Name: Catheters ANVISA registration number: 80145901748 Risk Class: IV Affected model: D134701, D134702, D134804, D134805 Affected batch numbers: All batches of affected models |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP TEL 55 11 27882245 EMAIL VOLIVEI2ITSJNJCOM FABRICANTE DO PRODUTO BIOSENSE WEBSTER INC 3333 DIAMOND CANYON ROAD DIAMOND BAR CA 91765 ESTADOS UNIDOS DA AMÉRICA |
| Models | 80145901748, D134805, D134701, D134702, D134804 |
| Date | Nov 23, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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