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

Recall number

Z-0598-2019

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

Status

Terminated

Initiated

2018-07-06

Posted

not on file

Terminated

2020-12-02

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.

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 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

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,

Lot, serial or model codes

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

510(k) numbers

["K173087"]

PMA numbers

not on file

Product code

PEW

Firm FEI

3005791775

Firm city

Pleasanton

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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