# FDA recall Z-0262-2018

> **NXTHERA** · Class II · device recall initiated 2017-07-28.

## Product

Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA.    Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age with a prostate volume greater than or equal to 30cm3 and less than or equal to 80cm3. The Rezum System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0262-2018
- **Recalling firm:** NXTHERA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-28
- **Report date:** 2017-12-27
- **Termination date:** 2018-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0262-2018

## Citation

> AI Analytics. FDA recall Z-0262-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0262-2018. Source: US FDA. Licensed CC0.

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