Events

Recall of 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
    79196
  • Event Risk Class
    Class 2
  • Event Number
    Z-1171-2018
  • Event Initiated Date
    2017-09-22
  • Event Date Posted
    2018-03-01
  • 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=162626
  • 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 bypass - Product Code DTN
  • Reason
    The device is used as part of extracorporeal membrane oxygenation (ecmo) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
  • Action
    The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to ytamari@cirtec.com as soon as possible.

Device

BetterBladder
  • Model / Serial
    **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Product Description
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

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