Neotract Inc: Medical Device Recall in 2018 - (Recall #: Z-0598-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 6, 2018

Date Posted: December 19, 2018

Recall Number: Z-0598-2019

Event ID: 81576

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.

Status: Terminated

Product Quantity: 8,804

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

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated