Device Recall Boston Scientific, IMAGER II Urology Torque Catheter

  • Model / Serial
    Imager" II Catheters C1  5fr 65cm M0064003001 M0064003000  Catalogue #400-300  Lot/Batch Number: 00064016, 00065473, 00066117, 00067636, 00068586, 00069553, 00070089, 00070791, 00071534, 00072320,00073679, 00073780, 00076129.  Imager" II Catheters C2  5fr 65cm M0064003011 M0064003010  Catalogue #400-301   Lot/Batch Number:00063007, 00064018, 00065474, 00066588, 00067128, 00068068, 00073781, 00074282, 00075160, 00075362,00076130.  Imager" II Catheters  Straight 5fr 65cm M0064003021 M0064003020  Catalogue #400-302   Lot/Batch Number:00063008, 00064020, 00065475, 00066590, 00067130,00068069, 00069554, 00071536, 00071619, 00073784, 00074284, 00074829, 00075159.  Imager" II Catheters  Bern 5fr 65cm M0064003031 M00640030300 Catalogue #400-303   Lot/Batch Number:0064022, 00064918, 00065472, 00066119, 00066586,00067635, 00068584, 00068896, 00069555, 00069965, 00070090, 00070789, 00071532, 00071617, 00072318, 00073681, 00073778, 00074281, 00074828, 00076127.  Imager" II Catheters  JB1 5fr 65cm M0064003041 M0064003040 Catalogue #400-304  Lot/Batch Number:00064030, 00068587, 00069556, 00071535, 00071618,00073782, 00076131.  Imager" II Catheters  Straight 5fr 100cm M0064004021 M0064004020 Catalogue #400-402   Lot/Batch Number: 00066123, 00066589, 00068993, 00069557, 00070792,00072321, 00073783, 00074283, 00075363.  Imager" II Catheters  Bern 5fr 100cm M0064004031 M0064004030 Catalogue #400-403   Lot/Batch Number:00063006, 00064034, 00065926, 00070094, 00070788,00071616, 00073680, 00074827, 00076126.  Imager" II Catheters  JB1 5fr 100cm M0064004041 M0064004040 Catalogue #400-404   Lot/Batch Number: 00067129.  Imager" II Catheters  Bern 5fr 40cm M0064005031 M0064005030 Catalogue #400-503   Lot/Batch Number: 00064919, 00066121, 00066587, 00068585, 00068992,00070092, 00070790, 00071533, 00072319, 00073779, 00075161, 00076128.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.”
  • Source
    USFDA