Current

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide distribution
  • Product Description
    Current, Sterile EO, Model #/ Part #: || 1207-30/50020236-001, 60010739-207, 60010739-407; || 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; || 2207-30/ 50020238-001, 60010738-207; || 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; || CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; || CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; || CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; || CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; || CD1217-36/100011824; || CD1219-36/100002160, 100002864, 100011826; || CD1219-36Q/100004071, 100023301; || CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; || CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; || CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; || CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; || CD2217-36/100011828, 100046991, 60016124-401; || CD2219-36/100002139, 100002140, 100002862, 100011830; || CD2219-36Q/100023303
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

12 devices with a similar name

Learn more about the data here

  • Model / Serial
    All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors). The product was also distributed to Australia, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Japan, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom. There are no government accounts.
  • Product Description
    The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants
  • Manufacturer
7 more