Events

Recall of Device Recall mcompass 2channel Balloon Catheters

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

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
    77706
  • Event Risk Class
    Class 2
  • Event Number
    Z-3072-2017
  • Event Initiated Date
    2017-06-14
  • 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=157691
  • 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
    Catheter, rectal - Product Code GBT
  • Reason
    Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
  • Action
    The firm Medspira plans to contact all foreign and domestic consignees in regards to the recall. International consignees are to destroy recalled product by cutting the catheter shaft and balloon with scissors. It is also requested that their own customers be notified of the recall. Medspira plans to provide product replacement. Domestic customers are asked to return affected catheters to the recalling firm. Medspira indicates that they will cove shipping costs and replacements. All consignees are asked to complete and return the attached recall response form. For further questions please call, (612) 789-0013.

Device

Device Recall mcompass 2channel Balloon Catheters
  • Model / Serial
    Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom
  • Product Description
    mcompass 2-channel Balloon Catheters || The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.
  • Manufacturer
    Medspira, Llc

Manufacturer

Medspira, Llc
  • Manufacturer Address
    Medspira, Llc, 2718 Summer St NE, Minneapolis MN 55413-2820
  • Manufacturer Parent Company (2017)
    Medspira Llc
  • Source
    USFDA