Devices

Device Recall Covidien Trellis 6 Peripheral Infusion System

  • Model / Serial
    Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740.   Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042.   Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423.   Model BVT312030, Lot numbers: 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. || Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
  • Manufacturer
    Covidien
  • 1 Event

Manufacturer

Covidien
  • Manufacturer Address
    Covidien, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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