“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.”
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps || UPN/Catalog Number: MOO513330 || The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). || Single packaged units of M00513330 are not sold individually.
Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
Description du dispositif
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
Description du dispositif
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.