Class 2 Device Recall Rezum System

• Date Initiated by Firm: July 28, 2017
• Create Date: December 18, 2017
• Recall Status: Terminated on August 01, 2018
• Recall Number: Z-0262-2018
• Recall Event ID: 77797
• 510(K)Number: K160417
• Product Classification: Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
• 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.
• Code Information: UDI 08855757006010. Lot Number of Outside Cases (Pack Lot) 2017020920 with Lot Number of Inside Boxes (Product Lot) 2017011612 and Exp Date 2018-01-31: Lot Number of Outside Cases (Pack Lot) 2017030286 with Lot Number of Inside Boxees (Product Lot) 2017011187 and Exp Date 2018-01-31.
• Recalling Firm/ Manufacturer: NXTHERA; 7351 Kirkwood Ln N; Maple Grove MN 55369-5201
• For Additional Information Contact: 651-484-6095
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNS