Events

Recall of Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010

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

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
    76514
  • Event Risk Class
    Class 2
  • Event Number
    Z-2782-2017
  • Event Initiated Date
    2017-02-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153408
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    One side of the mobicath bi-directional guiding sheath pouch may not be sealed.
  • Action
    Consignee was sent a Greatbatch "Urgent Medical Device Recall" letter dated February 15, 2017 via UPS and email . The letter was addressed to Biosense Webster, Inc. The letter described the product involved in the recall, Reason for Recall, Risk to Health,& Instructions to Biosense Webster. Advised consignee to quarantine and return the devices, complete and return the field Recall Response Form to Stericycle, and to communicate the recall to their customers and end users. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8184 from 8:00 AM (CST) to 5:00 PM (CST), or e-mail us at FieldActionCenter@Greatbatch.com

Device

Device Recall Biosense Webster MobiCath BiDirectional Guiding Sheath, Model D140010
  • Model / Serial
    Model D140010, Lots: W3332609, W3338632, W3338635, W3338707, W3348350, W3348351, W3352503, W3359665, W3363850, W3363851, W3370052, W3374699, W3374700, W3379647, W3379650, W3384700, W3384701, W3390549, W3390551, W3397877, W3397879, W3397950, W3407814, W3407815, W3436351, W3436355, W3436356, W3436358, W3441735, W3441737, W3446767, W3446769, W3449392, W3451862, W3451863, W3455438,  W3455439, W3455440, W3459354, W3462467, W3462470, W3470335,  W3470336, W3483637, W3493240, W3497507, W3501348, W3501349,  W3581648, X3489776, X3497121, X3497510, X3501344, X3501345, X3503248,  X3507599, X3514814, X3518116, X3565743, X3581652, X3586059, X3592497.   Model D140011, Lots:
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA
  • Product Description
    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). || The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA