Recall Z-0488-2021— Coloplast Manufacturing US, LLC
Class II · Terminated
Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2020-10-23, terminated 2021-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.. Reason: Potential increased occurrence of pump fracture over the lifetime of the device..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-23
- Terminated
- 2021-05-13
- Firm location
- Minneapolis, MN, United States
Product description
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Reason for recall
Potential increased occurrence of pump fracture over the lifetime of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.