Rotablator™ Rotational Atherectomy System Console Kit 22020-039-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729719601), received between Nov 7, 2017 and May 14, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE TURBINE PRESSURE CONTROLLER KNOB WAS NOT WORKING PROPERLY AND THE PRESSURE WAS UNABLE TO BE STABILIZED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608116 ↗
• MalfunctionFeb 21, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DISPLAY ON THE DEVICE WAS NOT FUNCTIONING A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS NO ROTATIONS PER MINUTE (RPM) DISPLAY ON THE CONSOLE WHILE THE BURR WAS ROTATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONSOLE. NO COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359097 ↗
• MalfunctionSep 11, 2018No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WERE NO RPM DISPLAY. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WERE NO RPM DISPLAY ON THE CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7865092 ↗
• MalfunctionMay 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SPEED COULD NOT BE ADJUSTED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. IT WAS NOTED THAT THE SPEED COULD NOT BE ADJUSTED AND WOULD STAY LOCKED AT 250,000 RPM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7550290 ↗
• MalfunctionNov 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SPEED WAS FLUCTUATING. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO MAINTAIN DESIRED ROTATIONS PER MINUTE AND THE SPEED WAS FLUCTUATING. ALSO, AIR LEAKAGE WAS NOTED. THE CONSOLE AND THE FOOT PEDAL WERE REPLACED. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7005738 ↗