Class 2 Device Recall UroLift System

• Date Initiated by Firm: July 06, 2018
• Create Date: December 12, 2018
• Recall Status: Terminated on December 02, 2020
• Recall Number: Z-0598-2019
• Recall Event ID: 81576
• 510(K)Number: K173087
• Product Classification: Implantable transprostatic tissue retractor system - Product Code PEW
• Product: UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
• Code Information: Model: AN00141 (US) and AN00142 (OUS); Catalog No.: UL400-4; Lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132
• FEI Number: 3005791775
• Recalling Firm/ Manufacturer: Neotract Inc; 4473 Willow Rd Ste 100; Pleasanton CA 94588-8570
• For Additional Information Contact: 925-401-0700
• Manufacturer Reason for Recall: Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.
• FDA Determined Cause: Finished device change control
• Action: On July 6, 2018, the firm sent an Urgent Medical Device Recall Notification to customers via Federal Express next day Service informing them that upon implant deployment, the capsular tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of existing known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle. It is important to note that this issue impacts only the delivery device. The implant is not impacted. Any implants that have been delivered with the device are not affected. The notification also provides instructions and the following actions to take: 1) If you HAVE affected stock: a. Immediately discontinue use and quarantine any products with the lot numbers listed above, so that the affected products can be returned to the firm. b. Please return the product as follows: i. Complete the enclosed Recall Acknowledgement Form and email to uroliftrecall@teleflex.com or fax it to (925) 401-0699, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will issue you a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to the firm. ii. Write the RGA Number on each box and follow the shipping instructions provided by the firm's Customer Service. 2) If you HAVE NO affected stock: a. Please complete the enclosed Recall Acknowledgement Form and email to uroliftrecall@teleflex.com or fax it to (925) 401-0699, Attn: Customer Service. b. This will allow us to document your receipt of this letter. If customers have any other questions, they can contact their local Urology Consu
• Quantity in Commerce: 8,804
• Distribution: US: AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV,
• 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 = PEW