Coloplast Titan Pump Recall: Potential increased pump fracture risk
Coloplast recalls Titan Pump devices for men with erectile dysfunction implants due to potential increased fracture risk over time. No remedy specified in official notice.
Recall notice
Potential increased occurrence of pump fracture over the lifetime of the device.
Contact the company
What happened, in plain English
Coloplast is recalling Titan Pump devices intended for men with erectile dysfunction implants. The recall is due to a potential increased risk of pump fracture over the device's lifetime. This could lead to injury if the pump breaks. Read more at govinfonow.com/recall/64059-coloplast-titan-pump-recall-potential-increased-pump-fracture-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64059-coloplast-titan-pump-recall-potential-increased-pump-fracture-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0488-2021
Cite this page
“Coloplast Titan Pump Recall: Potential increased pump fracture risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64059-coloplast-titan-pump-recall-potential-increased-pump-fracture-risk. Based on FDA recall #Z-0488-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0488-2021%22&limit=1).
Why it’s dangerous
The hazard is a potential increased occurrence of pump fracture over the lifetime of the device. This could happen due to normal use over time, but the exact mechanism isn't specified in the recall notice.
Who’s affected
Men who use Titan Pump devices for erectile dysfunction implants are affected. Those with the specific model numbers listed in the recall are most at risk.
How to tell if you have this one
Check for the model numbers listed in the recall (e.g., 5585215, 5637061, etc.) on the device packaging or label. The Titan Pump is intended for male patients with erectile dysfunction who are candidates for penile prosthesis implants.
- Brand
Coloplast- Category
Medical device
What to do — step by step
Check Device Model
Look for the model numbers listed in the recall on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 41 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0488-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0488-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.