Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
Product Description
TWISTER PLUS 26mm Rotatable Retrieval Device || (Box of 5 configuration) || Universal Product Number (UPN):M00561421. || Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. || Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
“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.”