“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.”
Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
Description du dispositif
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.
Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
Description du dispositif
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
Description du dispositif
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515.
Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
Description du dispositif
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
Description du dispositif
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519.