Z-0598-2019Class II

UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R...

Name: Z-0598-2019 UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R...
Creator: Neotract Inc
Published: 2018-07-06
License: https://open.fda.gov/license/

Neotract Inc / initiated 2018-07-06 / Terminated

FDA source

Neotract Inc began a recall of UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract on 2018-07-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0598-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-06
Posted: 2018-12-12
Terminated: 2020-12-02
Recalling firm: Neotract Inc
Product: UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Product code: PEW Implantable Transprostatic Tissue Retractor System
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 root 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 [email protected] 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 [email protected] 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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0598-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0598-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-12

Product code PEW

K173087Class IIUroLift System (UL400 and UL500)Neotract, Inc. / cleared 2017-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)