Product: AMPHIRION DEEP OTW - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. Anvisa registration No. 10339190532. Products affected: AMD015020002 AMD020120152 AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD015020151 AMD020150002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD015020152 AMD020150152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD020040002 AMD025040152 AMD030080002 AMD035150002 AMD040150152 AMD354210152. AMD020040152 AMD025080152 AMD030080152 AMD035150152 AMD225210002. AMD0200120002 AMD025120002 AMD030120002 AMD040040152 AMD225210152. AMD0200160152 AMD025120152 AMD030120152 AMD040080002 AMD253210002. AMD02012002 AMD025150002 AMD030150002 AMD040080152 AMD253210152 ... #### UPDATE (01/14/2016): According to the company, all the codes of the products affected globally were erroneously reported, but in Brazil only one code was affected (AMD225210152), of which only 03 lots are under risk - 209532760, 209507756 and 209507757. The above list (see above) does not therefore apply in its entirety to Brazil.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA