Events

Recall of Titan OTR Inflatable Penile Prosthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Manufacturing US, 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
    53531
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-2010
  • Event Initiated Date
    2009-10-06
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85729
  • 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
    Device, impotence, mechanical/hydraulic - Product Code FHW
  • Reason
    Coloplast determined that a portion of titan otr pumps were manufactured using a process that where validation activities were not completed. the titan otr pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. coloplast is not recommending product explant because there are no identified risks since the prod.
  • Action
    Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.

Device

Titan OTR Inflatable Penile Prosthesis
  • Model / Serial
    Lot 1919244.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- FL, GA, NC.
  • Product Description
    Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. || Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Manufacturer Address
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3430
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA