# FDA recall Z-0598-2019

> **Neotract  Inc** · Class II · device recall initiated 2018-07-06.

## Product

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.

## 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,

## Key facts

- **Recall number:** Z-0598-2019
- **Recalling firm:** Neotract  Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-06
- **Report date:** 2018-12-19
- **Termination date:** 2020-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0598-2019

## Citation

> AI Analytics. FDA recall Z-0598-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0598-2019. Source: US FDA. Licensed CC0.

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