Stent, Colonic, Metallic, Expandable
FDA adverse event reports and recall history for stent, colonic, metallic, expandable (product code MQR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,316
- Deaths
- 104
- Injuries
- 625
- Malfunctions
- 585
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-08-31TerminatedProcess control
Boston Scientific Ultraflex Precision Colonic Stent System Material/UPN/Catalog Number: M00557360
Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- TerminatedLabeling False and Misleading
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
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