“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.”
Worldwide Distribution - US (nationwide) including DC and Puerto Rico, and in the states of AK, AL, AR. AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY and the countries of Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Ireland, Italy, Luxembourg, Macedonia, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and Ukraine.
Description du dispositif
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: || Product Description Material Number (UPN) || Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 || Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 || Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 || Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 || Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 || Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 || Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 || Guiding Sheath 6F, 65 cm, ST, TB H74939277665120 || Guiding Sheath 6F, 90 cm, ST, CC H74939277690110 || Guiding Sheath 6F, 90 cm, ST, TB H74939277690120 || Guiding Sheath 6F, 90 cm, MP, CC H74939277690210 || Guiding Sheath 6F, 90 cm, MP, TB H74939277690220 || Guiding Sheath 7F, 45 cm, ST, CC H74939277745110 || Guiding Sheath 7F, 45 cm, ST, TB H74939277745120 || Guiding Sheath 7F, 45 cm, MP, CC H74939277745210 || Guiding Sheath 7F, 45 cm, MP, TB H74939277745220 || Guiding Sheath 7F, 65 cm, ST, CC H74939277765110 || Guiding Sheath 7F, 65 cm, ST, TB H74939277765120 || Guiding Sheath 7F, 90 cm, ST, CC H74939277790110 || Guiding Sheath 7F, 90 cm, ST, TB H74939277790120 || Guiding Sheath 7F, 90 cm, MP, CC H74939277790210 || Guiding Sheath 7F, 90 cm, MP, TB H74939277790220 || Guiding Sheath 8F, 45 cm, ST, CC H74939277845110 || Guiding Sheath 8F, 45 cm, ST, TB H74939277845120 || Guiding Sheath 8F, 45 cm, MP, CC H74939277845210 || Guiding Sheath 8F, 65 cm, ST, CC H74939277865110 || Guiding Sheath 8F, 65 cm, ST, TB H74939277865120 || Guiding Sheath 8F, 90 cm, ST, CC H74939277890110 || Guiding Sheath 8F, 90 cm, ST, TB H74939277890120 || Product Usage: The Chariot Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight or preformed multipurpose tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement.
Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.
Description du dispositif
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. || Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
Boston Scientific, PT Graphix Magnet J-TIP Guidewire || with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . || Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip. || The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
“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.”
“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.”
“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.”
“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.”
“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.”