System, Hemodialysis, Access Recirculation Monitoring
FDA adverse event reports and recall history for system, hemodialysis, access recirculation monitoring (product code MQS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 271
- Deaths
- 12
- Injuries
- 6
- Malfunctions
- 229
Reports per year
Source: FDA adverse event reports by year received, 2005–2013. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-03-18TerminatedProcess control
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
Monitor system, hemodialysis, access recirculation monitoring automatically
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