Events

Safety Alert for Copilot Haemostatic Valve. Lot: 3022551 (50 pcs.). Pacemaker Insignia - Model 1194. Lots: 139232, 139249, 139338, 139355, 139356, 139400, 139416, The invention relates to a method for the preparation of a compound of the formula: ## STR1 ## in which the compounds of the present invention are incorporated herein by reference in the same manner as those in which it is incorporated herein by reference: 139422, 131682, 141642, 141652, 141655, 141656, 141659, 141661, 141662, 141875, 141891, 142090, 142097, 142099, 142106, 142114, 142115, 142118, 142122, 142126, 142127, 142131, The Pacemaker is designed to be used in conjunction with the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, the Pacemaker, and the Pacemaker. : 409638, 409639, 409640, 409641, 409643, 409644, 409645, 409646, 409647, 409648, 409649, 409654, 409655, 409657, 409661 Flexible Active Fixing Electrode 52 cm. Lots: 162654, 162657, 162658, 162660, 162661, 162666, 162668, 162932, 163032, 163040, 163054, 163056, 163058, 163070, 163086, 163149, 163150, 163151, 163152, 163154, 163155, 163514, 163515, 163520, 163537, 163539, 163552, 163553, 163559, 163562.////Electrical Flexing Anchor Flextend 59 cm. Lots: 153719, 153748, 153756, 153761, 153814, 153853, 153859, 153881, 153897, 153900, 153901, 153903, 153904, 153995, 154019, 154664, 154747, 154749, 154752, 154758, 154761, 154809, 154810, 154811, 154812, 154813, 154814, 154827, 154862, 154863, 154864, 154865, 154868, 154888, 155130, 155131, 155150, 155167, 155168, 155169. Fineline Electrode No. 4457. Lots: 359333, 961017, 361018, 361072, 361073, 361119 //// Fineline Electrode II - Model 4471. Lots: 313844, 313845, 313871, 314412, 314435, 314444, 314459, 314512, 314528, 314532, 314533, 314535, 314536, 314537, 314540, 314559. //// --- Fineline Electrode - Model 4473. Lots: 315463, 315464, 315489, 315486, 315487, 315988, 315989, 315995, 315998, 316004, 316006, 316008, 316016, 316019, 316022, 316030, 316034, 316036 , 316038, 316042, 316043, 316141, 316178, 316179, 316182, 316183, 316370, 316376, 316381, 316384.////

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

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
    745
  • Date
    2003-09-25
  • 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
    considering the provisions in Article 6 of Law no. 9,782, of January 26, 1999; considering the provisions of Article 6, Item I, and Article 12, paragraph 3, Section III, of Law no. 8,078, of September 11, 1990; considering the Theft Communication of Products for Health of the company GUIDANT DO BRASIL LTDA., File No. 183502 / 03-5; considering the Bulletin of Occurrence nº 004366/2003, issued by the 27th Police Station of the Civil Police of the State of São Paulo; considering the Bulletin of Occurrence nº 005752, issued by the 35th Police Station of the Civil Police of the State of São Paulo;
  • Reason
    Health product theft communication ------------------------------------------ ------------------------- continuation product description: fineline electrode - model 4474. lots: 306443, 306445, 306469, 306470, 306472, 306477 / /// easytrak electrode 90 cm - model 4513. lots: 306748, 306883, 306968, 306969, 307020, 307043.////stranded flextend j 52 cm. lot: 103006 (20 pcs.) ///// flextend stylus j 58 cm. lot: 103008 (20 pcs.). //// flextend stylus 52 cm. lot: 101011 (20 pcs.). flextend stylus 58 cm. lot: 101013 (20 pcs.) //// finishing guide wire - model 6732. lots: 2100751 (10 pcs.), 3022751 (20 pcs.). /// inflator device kit indeflator 20/30. lots: 3012351 (2 pcs.), 3132551 (2 pcs.), 3050652 (26 pcs.) ////. middle balance guide wire .014x190. lots: 3041072 (6 units), 3030371 (15 units), 3042371 (10 units), 3021872 (2 units), 3021172, 2120352 (2 units). catheter viking guide jl 3.5 6 f. lot: 3031951.//// catheter viking guide 1.0 7f. lot: 3011751, 3061051.//// catheter viking guide 2.0 6f. lot: 3031951 (3 pcs.). / / catheter of dilation cross sail 2.5x10. lots: 3042752, 3042351. cross sail dilatation catheter 2.5x15mm. lot: 2112552.//// cross sail dilatation catheter 2.5x20mm. lots: 2100751, 3041753 (3 pcs.). / / catheter of dilation cross sail 2.5x30mm. lot: 2120551./// coronary stent multi-link pixel 2.5x18. lot: 3041451.//// sist. of coronary stent multi-link penta 2.75x15. lot: 204303l.//// sist. of multi-link penta 2.75x18 coronary stent. lot: 2052832.//// sist. of coronary stent multi-link penta 2.75x23. lot: 2062432.//// of multi-link penta 3.0x18 coronary stent. lot: 3051452 (2 pcs.). /// sist. of multi-link penta 3.0x23 coronary stent. lot: 3060351.//// sist. of multi-link penta 3.0x28 coronary stent. lot: 2080631./// of coronary stent multi-link penta 3.0x33. lot: 2060531.//// sist. of 3.5x13 multi-link penta coronary stent. lot: 3052951.//// sist. of 3.5x18 multi-link penta coronary stent. lot: 3052851.//// sist. of 3.5x28 multi-link penta coronary stent. lot: 2070231.//// wire guide floppy ii .014x190. lot: 3042251.
  • Action
    To determine, as a measure of health interest, the seizure, throughout the national territory, of the products listed below, as they are full batches of stolen health products.

Device

Copilot Haemostatic Valve. Lot: 3022551 (50 pcs.). Pacemaker Insignia - Model 1194. Lots: 139232,...

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA