Titan recallZ-1367-2023 · Coloplast Manufacturing US, LLC · initiated Mar 1, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Coloplast Manufacturing US, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email [email protected].
Recall details
- Recall number
- Z-1367-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 1, 2023
- Posted by the FDA
- Apr 12, 2023
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 15 units
- Product code
- FHW
- FDA submissions
- P000006
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Product description
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Code information (models, lots, serial numbers)
UDI/DI 05708932539128, Lot Numbers: 8849582, 8849603, 8904185
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Titan ES2818Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall222 reports
Product lines
Other devices under the same FDA submission
65 devices cleared under P000006 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Titan ES2920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall862 reports
- Titan ES2922Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall1 death758 reports
- Titan ES2918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic577 reports
- Titan ES8920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall476 reports
- Titan ES8922Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall334 reports
- Titan 517750Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall258 reports
- Titan ES8918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall225 reports
- Titan ES8820Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall192 reports
- Titan ES2820Coloplast A/S · Device, Impotence, Mechanical/Hydraulic232 reports
- Titan ES2916Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall178 reports
- Titan ES2822Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall149 reports
- Titan 90-9000KCColoplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall138 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91800).
- Z-1359-2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1360-2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1361-2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1362-2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1363-2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1364-2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1365-2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1366-2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1368-2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1369-2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1370-2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1371-2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1372-2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1373-2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1374-2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1375-2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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