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U.S. Department of Health and Human Services

Class 2 Device Recall Rezum System

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  Class 2 Device Recall Rezum System see related information
Date Initiated by Firm July 28, 2017
Create Date December 18, 2017
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = NxThera, Inc.
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