Device Recall Gelweave (TM) Vascular Prostheses

  • Model / Serial
    731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
  • Product Description
    Gelweave (TM) Vascular Prostheses || Manufactured by - VASCUTEK Ltd || a TERUMO company
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Vascutek, Ltd., Newmains Avenue, Inchinnan United Kingdom
  • Manufacturer Parent Company (2017)
  • Source
    USFDA