Manufacturers

Covidien, PLC

  • Manufacturer Address
    Covidien, PLC, 5920 Longbow Dr, Boulder CO 80301-3202
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • 3 Events

3 devices in the database

Device Recall LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider
  • Model / Serial
    Lot numbers: S1CB010X, S1CB011X, S1DB001X, S1DB002X, S1EB012P, S1EB013P, S1EB014P, S1FB031PX, S1FB032PX, S1FB033PX, S1FB035X, S1FB036X, S1FB037X, S1FB038X, S1FB039X, S1FB049X, S1FB050X, S1FB051X, S1GB005X, S1GB006X, S1GB007X, S1HB010, S1HB011, S1HB012, S1HB013P. S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatamala, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, and Vietnam.
  • Product Description
    LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China. || Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
Device Recall LigaSure V 5 mm Dolphin Tip Laparoscopic
  • Model / Serial
    Lot numbers: S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatamala, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, and Vietnam.
  • Product Description
    LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., || Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
Device Recall Evident MWA Generator
  • Model / Serial
    Serial Numbers:  XP7K0101R to XP7K0120R, XP7L0121R to XP7L0140R, XP8B0141R to XP8B0167R, XP8C0168R to XP8C0231R, XP8D0232R to XP8D0320R, XP8E0321R to XP8E0390R, XP8F0391R to XP8F0485R, XP8H0578R to XP8H0615R, XP8I0626R to XP8I0660R, XP8J0661R to XP8J0690R, XP8L0701R to XP8L0730R.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK.
  • Product Description
    Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. || Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.