Safety Alert for CATHEDRAL OF DILATACAO Rx PTCA - Registration number ANVISA: 80145900992 - Lots: 13315455 or smaller.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The current worldwide complaint rates are 0.03% for Fire Star angioplasty catheters and 0.008% for Dura Star angioplasty catheters. According to the company, in Brazil, no product complaint by any customer was received so far, 29.01.2008. Possibility of a "slow deflation" or "no deflation" during inflation of the catheter flask. If a catheter presents "no deflation" conditions in a coronary artery or coronary artery bypass, complete occlusion of the blood vessel may occur, potentially resulting in arrhythmias, including ventricular fibrillation, acute myocardial infarction, coronary artery injury or need for surgery. The company also reports that up to now, they have received five reports (outside Brazil) of ischemic episodes during procedures, however, no permanent injuries have been reported. According to company information were imported by J & J ;: 1749. Of this amount, 529 units were sent to customers and distributors. The remainder is held by J & J .;