U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Stent, carotid - Product Code NIM
원인
Two production lots of the protege rx tapered carotid stent systems (secx-10-7-40-135, lot # 9922452 & sepx-8-6-40-135, lot # 9922795) because of a product labeling error.
조치
Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
제품 설명
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
“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.