“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 - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen
Description du dispositif
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. || The following products being recalled: || Imager" II Catheters C1 || 5fr 65cm || M0064003001 M0064003000 || 400-300 || Imager" II Catheters C2 || 5fr 65cm || M0064003011 M0064003010 || Catalog # 400-301 || Imager" II Catheters || Straight 5fr 65cm || M0064003021 M0064003020 || Catalog #400-302 || Imager" II Catheters || Bern 5fr 65cm || M0064003031 M0064003030 || Catalog #400-303 || Imager" II Catheters || JB1 5fr 65cm || M0064003041 M0064003040 || Catalog #400-304 || Imager" II Catheters || Straight 5fr 100cm || M0064004021 M0064004020 || Catalog #400-402 || Imager" II Catheters || Bern 5fr 100cm || M0064004031 M0064004030 || Catalog #400-403 || Imager" II Catheters || JB1 5fr 100cm || M0064004041 M0064004040 || Catalog #400-404 || Imager" II Catheters || Bern 5fr 40cm || M0064005031 M0064005030 || Catalog #400-503 || The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.
Model Catalog: M0064003011 (Lot serial: see mfr); Model Catalog: M0064003021 (Lot serial: see mfr); Model Catalog: M0064003031 (Lot serial: see mfr); Model Catalog: M0064003041 (Lot serial: see mfr); Model Catalog: M0064003001 (Lot serial: see mfr); Model Catalog: M0064004031 (Lot serial: see mfr); Model Catalog: M0064004041 (Lot serial: see mfr); Model Catalog: M0064005031 (Lot serial: see mfr); Model Catalog: M0064004021 (Lot serial: see mfr)
Worldwide Distribution -- United States (AL, AZ, AR, CA, CO,CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VT, VA, WA, WV and WI), United Arab Emir., Dutch Antilles, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Israel, Italy, South Korea, Kuwait, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Puerto Rico, Portugal, Qatar, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, and South Africa.
Description du dispositif
Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: || Product Description and Material/UPN/Catalog Number || Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) || M0064003011 (outer box); || Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) || M0064003021 (outer box) and || Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) || M0064003031 (outer box) || The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.