Events

Safety Alert for FLEXIMA, FLEXIBLE URETHANE CATHETERS: (1) 4 FR X 70 CM, (2) 5 FR X 70 CM, (3) 6 FR X 70 CM, (4) 7 FR X 70 CM, (5) 8 FR X 70 CM. ITEMS NO.: (1) 400-215, (2) 400-216, (3) 400-217, (4) 400-218, (5) 400-219; ALL LOT NUMBERS.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    85
  • Date
    2001-05-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    07/07/2001 - BOSTON SCIENTIFIC DO BRASIL LTDA ANNOUNCES THAT BOSTON SCIENTIFIC CORPORATION LTDA STARTED A VOLUNTARY COLLECTION OF ALL LOTS OF CODES 400-215, 400-216, 400-218 AND 400-219 OF THE FLEXIBLE DRAIN CATECHISM PRODUCT , DUE TO THE FACT OF RECEIVING SOME NOTICES RELATED TO THE RADIOPACA TIP WHICH RELIEVED FROM CATHETER, AND THAT NO COMPLICATION OR SURGICAL INTERVENTION WAS REPORTED, HOWEVER, THE COMPANY DECIDED TO COLLECT THE PRODUCT FROM THE MARKET TO PREVENT FUTURE OCCURRENCE. IT FURTHER INFORMES THAT THE PRODUCT IS REGISTERED IN BRAZIL HAS NEVER BEEN IMPORTED BY BOSTON SCIENTIFIC DO BRASIL LTDA JUST FOR THE FACT THAT IT WAS REMOVED FROM THE MARKET. FOR FURTHER CLARIFICATION: (11) 56448500
  • Reason
    The radiopacle flexible tip can release the catheter. the distributor started the removal with a letter sent on november 30, 2000. the signature given no information to ecri.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE BOSTON SCIENTIFIC REMOVAL LETTER ON NOVEMBER 30, 2000. IDENTIFY, ISOLE AND DO NOT USE THESE PRODUCTS. FOR FURTHER INFORMATION CONTACT YOUR BOSTON SCIENTIFIC REPRESENTATIVE OR PHONE (0021-1-508-650-8000).

Device

FLEXIMA, FLEXIBLE URETHANE CATHETERS: (1) 4 FR X 70 CM, (2) 5 FR X 70 CM, (3) 6 FR X 70 CM, (4) 7...

Manufacturer

Boston Scientific
  • Source
    ANVSANVISA