Recall Z-1372-2023— Coloplast Manufacturing US, LLC
Class II · Ongoing
Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2023-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis. Reason: A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-01
- Firm location
- Minneapolis, MN, United States
Product description
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Reason for recall
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.