Nxthera recalls
Nxthera appears in 1 official U.S. recall notice indexed by RecallRadar, most recently on 2017-12-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 1 |
|---|---|
| Published | 2017-12-27 |
| By agency | FDA Device (1) |
| By classification | Class II (1) |
| By status | terminated (1) |
| Distribution named in notices | AL, AZ, CA, CO, FL, GA, IL, MA, MI, MN, MO, NE, NJ, NY, OH, PA, TN, UT, WA |
Recalls
- Rezum System, Vapor BPH Ablation System, Model Number D2201-003
FDA Device · Class II · 2017-12-27 · Nxthera
Reason: 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.