Events

Recall of Device Recall Bigger BetterBladder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Circulatory Technology 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
    55137
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2010
  • Event Initiated Date
    2009-06-03
  • Event Date Posted
    2010-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90000
  • 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
    reservoir, blood, cardiopulmonary - Product Code DTN
  • Reason
    During an fda inspection, it was discovered that the firm had conducted a silent recall of its bigger better bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.
  • Action
    The firm, Circulatory Technology, Inc., sent an email to Bigger Better-Bladder end user accounts on 6/03/09 and again on 6/13/09. The firm followed up with phone calls to the user customers. The emails and calls discussed the product, problem and the actions to be taken by the customers. The customers are ask to examine their stock of Bigger Better-Bladder for the affected units and then visually examine each unit to assure that adhesive has been applied and when the tube is bent away from cap, no separation is visible along the joint between the two according to the picture provided. The customers should return for full credit or a replacement of any product that has a separation of the seal. Please feel free to contact Mr. Yehuda Tamari at 516-624-2424 with any questions.

Device

Device Recall Bigger BetterBladder
  • Model / Serial
    Lot Number 9910-18907 (exp. 10/2011)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
  • Product Description
    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

Circulatory Technology Inc
  • Manufacturer Address
    Circulatory Technology Inc, 21 Singworth Street, Oyster Bay NY 11771-3703
  • Manufacturer Parent Company (2017)
    Circulatory Technology Inc
  • Source
    USFDA