Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Description du dispositif
CATHETER Z26EBU40A Z2 6F 110CM || CATHETER Z26EBU40A Z2 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Number: Z26EBU40A
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Description du dispositif
CATHETER Z26EBU35A Z2 6F 110CM EB35 || Z26 EBU35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: Z26EBU35A
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Description du dispositif
6F Z2 AR 2.0 110CM || CATHETER Z26AR20A Z2 6F 110CM AR20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: Z26AR20A
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Description du dispositif
6F Z2 AL 3.0 110CM || CATHETER Z26AL30A Z2 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: Z26AL30A
Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
Description du dispositif
6F Z2 AL 2.0 110CM || CATHETER Z26AL20A Z2 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Code: Z26AL20A
“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.
“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.