Neotract Recalls UroLift System Due to Capsular Tab Delivery Failure
Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional failure that increases the risk of known injuries (bleeding, tissue trauma) and treatment failure, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Neotract Inc. is recalling the UroLift System (Catalog No. UL400-4) due to a potential failure in the delivery of the capsular tab. The recall covers 8,804 units distributed across numerous US states and internationally.
The issue occurs when the needle is retracted after deployment into the prostate, but the capsular tab is not delivered, leaving no implant behind. This failure can result in a delay in completing the treatment or an inability to complete the treatment for the patient.
The use of the recalled device may increase the frequency of known risks associated with the product, including bleeding and tissue trauma related to needle delivery. Healthcare providers should stop using the affected devices and contact Neotract for further instructions.
The recalled product
- Product
- UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
- Manufacturer
- Neotract Inc
- Affected units
- 8,804
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
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