Coloplast Titan OTR Inflatable Penile Prosthesis,18cm… recallZ-0171-2010 · Coloplast Manufacturing US, LLC · initiated Oct 6, 2009
Terminated All recalls posted in November 2009
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
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
FDA root cause category: Process control
What the company is doing
Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.
Recall details
- Recall number
- Z-0171-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 6, 2009
- Posted by the FDA
- Nov 10, 2009
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 3
- Product code
- FHW
- FDA submissions
- P000006
- 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.
Code information (models, lots, serial numbers)
Lot 1919244.
Other devices under the same FDA submission
66 devices cleared under P000006 — the recall does not name any of them by identifier. 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 ES2818Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall222 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
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 18, 2026. Text above is shown as published by the FDA.
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