Recall Z-0598-2019— Neotract Inc

Name: FDA recall Z-0598-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-06

Class II · Terminated

Class II FDA medical device recall by Neotract Inc, initiated 2018-07-06, terminated 2020-12-02. It names one FDA 510(k) clearance: K173087. Product: UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract. Reason: 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..

Recalling firm: Neotract Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-06
Terminated: 2020-12-02
Firm location: Pleasanton, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173087 — UroLift System (UL400 and UL500)Neotract, Inc.·cleared 2017-12-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.