Implantable Transprostatic Tissue Retractor System
FDA adverse event reports and recall history for implantable transprostatic tissue retractor system (product code PEW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 461
- Deaths
- 12
- Injuries
- 229
- Malfunctions
- 220
Reports per year
Source: FDA adverse event reports by year received, 2013–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-08-05Open, ClassifiedUnder Investigation by firm
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
There is the potential that during implant deployment, the device may not properly deliver a implant.
- TerminatedFinished device change control
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
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.
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