Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Libya, Luxembourg, Macau, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Romania, Saudia Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, and Vietnam.
Product Description
Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. || M001182830 18-283 11961001 RENEGADE HI FLO 80/20 || M001182840 18-284 11294909 RENEGADE HI FLO 105/10 || M001182850 18-285 12703162 RENEGADE HI FLO 105/20 || M001182860 18-286 11339895 RENEGADE HI FLO 115/10 || M001182870 18-287 12669789 RENEGADE HI FLO 115/20 || M001182880 18-288 11295844 RENEGADE HI FLO 135/10 || M001182890 18-289 12703088 RENEGADE HI FLO 135/20 || M001182900 18-290 11295637 RENEGADE HI FLO 150/10 || M001182910 18-291 12684437 RENEGADE HI FLO 150/20 || M001182980 18-298 11320970 RENEGADE HI FLO 105/10 KIT || M001182990 18-299 12721456 RENEGADE HI FLO 105/20 KIT || M001183000 18-300 11319972 RENEGADE HI FLO 115/10 KIT || M001183010 18-301 12703082 RENEGADE HI FLO 115/20 KIT || M001183020 18-302 11279134 RENEGADE HI FLO 135/10 KIT || M001183030 18-303 11296276 RENEGADE HI FLO 135/20 KIT
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”