Events

Recall of Device Recall BridgeAssurant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Ave Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25794
  • Event Risk Class
    Class 2
  • Event Number
    Z-0789-03
  • Event Initiated Date
    2003-02-27
  • Event Date Posted
    2003-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26485
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.
  • Action
    A letter was sent to each US commercial accounts via UPS overnight mailing on Saturday, March 1st, 2003 for delivery on Monday, March 3rd 2003. The notification instructs firm''s customers to sequester product from the specific lot numbers so that firm''s rep could assist in removing the affected product.

Device

Device Recall BridgeAssurant
  • Model / Serial
    Specific lots of 7 and 8 mm in diameter:  2E16E06, 2F05E10, 2F11E12, 2E15E01, 2F20E13, 2H06E02, V432C25E12, V432D04E14, 2D16E09, 2D29E08, 2E06E09, 2E28E15, 2G11E01, 2G10E01, 2H01E07, 2H15E06, 2K17E02, 2E21E01, 2H29E08, 2K24E02, V432D1E12, 2D12E12, 2D17E13, 2E10E13, 2E22E20, 2E24E10, 2E30E01, 2G15E01, 2G26E01, 2G24E10, 2K03E01, 2K17E01, 2L11E09, 2D30E02, 2E13E14, 2E21E14, 2E28E16, 2H19E18, 2L13E01, 2E07E13, 2E18E01, 2K23E02, 2E21E12, 2H06E03, V432C23E01, V432C29E11, 2D08E14, V432D05E12, 2D25E10, 2E16E16, 2G18E02, 2G26E23, 2H09E08, 2H14E05, 2K11E14, 2L07E06, 2E24E01, 2G24E11, 2H28E22, 2L08E04, V432C28E12, V432D02E09, 2D15E24, 2D24E13, 2E01E10, 2D18E12, 2E1415, 2E21E15, 2F24E13, 2G11E11, 2G17E01, 2G22E13, 2G26E01, 2H16E09, 2K15E03, 2K21E06, 2K21E05, 2L13E02, 2D24E12, 2D26E09, 2E15E25, 2F04E12, 2F18E13, 2H15E05, 2H21E10, 2J03E11, 2K03E07
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was released for distribution to 446 consignees nationwide. The recall was appropriately extended to the user level; i.e., Clinics, hospitals and medical Centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Medtronic AVE brand Bridge¿Assurant¿ Balloon Expandable Stent Delivery System || for Biliary Catheter;Model #s: || FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; || FB720VL, FB730VL, FB820VL, FB830VL; || FB720F, FB730F, FB740F, FB760F, FB820F, FB830F, FB840F, FB860F; || FB720L, FB730L, FB820L, FB830L
  • Manufacturer
    Medtronic Ave Inc

Manufacturer

Medtronic Ave Inc
  • Manufacturer Address
    Medtronic Ave Inc, 3576 Unocal Place, Santa Rosa CA 95403
  • Source
    USFDA