Devices

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
1 Event
- Recall of Titan OTR Inflatable Penile Prosthesis

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

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)