Rezum System — Class II medical device recall Z-0262-2018
Terminated recall by NXTHERA, reported 2017-12-27, distributed in AL, AZ, CA, CO, FL, GA, IL, MA…. Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and
| Recall number | Z-0262-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NXTHERA, Maple Grove, MN, United States |
| Recall initiated | 2017-07-28 |
| Classified | 2017-12-18 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2018-08-01 |
| Distributed | AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA |
| Quantity | 113 units |
| Lot numbers | 2017011187, 2017011612, 2017020920, 2017030286 |
| Model numbers | D2201-003 |
| Expiration dates | 2018-01-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0262-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.