UroLift System recalled for potential implant deployment failure
Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.
What this means for you
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: This is a Class II FDA recall for a risk-of-harm medical device where deployment failure is a potential complication. No illnesses or injuries are reported in the source material, per the rubric guideline for risk-of-harm products.
Plain-English summary
Neotract Inc is recalling 18,722 UroLift System REF UL400-4 devices distributed across the United States.
The UroLift System is a medical device used for urological implants. There is a potential that during implant deployment, the device may not properly deliver the implant.
Patients who have received one of the affected devices should contact their healthcare provider immediately to discuss their device and determine appropriate next steps. Healthcare providers should review the specific lot numbers and check if their patients received affected units.
The recalled product
- Product
- UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
- Manufacturer
- Neotract Inc
- Hazard
- device-malfunction
- deployment-failure
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 (3)
- UDI/DI: 00814932020049 & 00814932020001
- 73C2200911
- and 73C2201163
Distribution
Distributed in 45 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- IA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NY
- OH
- OK
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WI
- WV
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