Device Recall Convoy Advanced Delivery Sheath Kits

  • Model / Serial
    Batch Numbers: S1721 4 S1899 6 S2103 9 S2287 6 S2497 2 S1724 9 S1903 2 S2105 6 S2287 7 S2513 9 S1732 2 S1913 1 S2109 5 S2295 6 S2522 7 S1733 8 S1913 2 S2115 2 S2295 9 S2524 0 S1735 6 S1913 3 S2118 9 S2296 4 S2536 0 S1737 1 S1926 5 S2123 4 S2297 1 S2553 7 S1737 2 S1930 1 S2135 6 S2299 4 S2553 8 S1737 4 S1956 3 S2151 1 S2299 5 S2555 1 S1757 4 S1962 0 S2156 4 S2301 4 S2557 8 S1766 6 S1962 1 S2161 5 S2305 1 S2562 9 S1766 7 S1964 4 S2166 4 S2306 9 S2566 1 S1766 8 S1970 4 S2166 5 S2307 0 S2566 4 S1792 6 S2015 1 S2166 6 S2308 9 S2567 6 S1792 S2015 S2180 S2309 and S2579.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Convoy Advanced Delivery Sheath Kit, Model Numbers: || M0045660ST0, || M0045661ST0, || M0045662ST0, || M0045663ST0, || M0045665ST0, || M0045667ST0, || M0045670ST0, || M0045672ST0, || M0045675ST0, || M0045676ST0, || M0045690ST0, || M0045890ST0, || M0045748ST0 and || M0045749ST0. || Manufactured by Thomas Medical Products, Malvern, PA. || Product is intended for use to facilitate the intracardiac placement of interventional devices.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 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