Recall Z-0262-2018 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
NXTHERA
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 80
| Date | Jul 28, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified initially by sales representatives on or about July 18, 2017. Any affected devices were to be returned to NxThera. Additionally, a formal recall letter was mailed to customers on approximately July 28, 2017. NxThera's telephone contact information and FEDEX number will be provided on the verification form. For further questions, please call (763) 515-2084.. |
| Quantity | 113 units total |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160417 | Rezum System Nxthera, Inc., Mar 17, 2016 |