NxThera Rezum System Model D2201-003: Needle Bond Risk in BPH Treatment
NxThera recalls Rezum System (Model D2201-003) due to potential needle bond failure during prostate treatment. This may cause injury during BPH ablation procedures for men over 50 with specific prostate sizes.
Stop using this now
Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
Contact the company
What happened, in plain English
NxThera is recalling its Rezum System (Model D2201-003) for BPH treatment because the needle bond might not withstand the tension during prostate tissue deployment. This could lead to injury during the procedure if the system fails under normal use conditions. Read more at govinfonow.com/recall/73333-nxthera-rezum-system-model-d2201-003-needle-bond-risk-in.
Source Summary by GovInfoNow · govinfonow.com/recall/73333-nxthera-rezum-system-model-d2201-003-needle-bond-risk-in · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0262-2018
Cite this page
“NxThera Rezum System Model D2201-003: Needle Bond Risk in BPH Treatment.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73333-nxthera-rezum-system-model-d2201-003-needle-bond-risk-in. Based on FDA recall #Z-0262-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0262-2018%22&limit=1).
Why it’s dangerous
The needle bond in the Rezum System may not handle the tension forces required when deploying and retracting the shaped needle into prostate tissue. This could cause the needle to fail during treatment, potentially leading to injury.
Who’s affected
Men aged 50 or older with prostate volume between 30cm³ and 80cm³ who have been treated with the Rezum System (Model D2201-003) are affected. Those with larger or smaller prostates are not covered by this recall.
How to tell if you have this one
Check for the model number D2201-003 on the Rezum System packaging. The product was sold with specific lot numbers and expiration dates: 2017020920 (outside cases) and 2017011612 (inside boxes) expiring January 31, 2018, or 2017030286 (outside cases) and 2017011187 (inside boxes) expiring January 31, 2018.
- Brand
NxThera- Category
Medical device
What to do — step by step
Stop using it now
Immediately discontinue use of the Rezum System (Model D2201-003) if you have it.
Where it went and when
Where it was distributed
Distributed in 19 states.
FDA distribution: “USA Distribution to the states of : AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Utah, Washington.
Recall timeline
FDA terminated this recall 12 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.
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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-0262-2018 (July 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0262-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.