Events

Recall of Device Recall BiodivYsio

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular Devices.

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
    26854
  • Event Risk Class
    Class 2
  • Event Number
    Z-1141-03
  • Event Initiated Date
    2003-07-21
  • Event Date Posted
    2003-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28567
  • 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
    Stent, Coronary - Product Code MAF
  • Reason
    The medical device is misbranded in that the compliance chart of the stent diameter may allow overexpansion that may result in vessel damage.
  • Action
    On 7/21/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall BiodivYsio
  • Model / Serial
    Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.
  • Product Description
    BiodivYsio¿ SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; || Catalog #: B3225-10, Lot #: 010586G; || Catalog #: B3225-10, Lot #: 030176G; || Catalog #: B3225-15, Lot #: 010626G; || Catalog #: B3225-18, Lot #: 020246G.
  • Manufacturer
    Abbott Vascular Devices

Manufacturer

Abbott Vascular Devices
  • Manufacturer Address
    Abbott Vascular Devices, 400 Saginaw Drive, Redwood City CA 94063
  • Source
    USFDA