Rotablator™ H802224360021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729353317), received between Feb 19, 2021 and May 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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 16, 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 5, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DEVICE FAILURE TO ADJUST SPEED OCCURRED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO SWITCH BETWEEN HIGH AND LOW SPEED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THE PATIENT IS STABLE, SEDATED WITH LOCAL ANESTHESIA, AND WITH NO PATIENT COMPLICATION OR OTHER ADDITIONAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962397 ↗
• MalfunctionApr 4, 2025Defective Device; Activation Failure; Defective Device; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A CE ROTABLATOR WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE FOOT PEDAL DYNAGLIDE MODE WAS NOT WORKING. THE CASE WAS POSTPONED, AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778057 ↗
• MalfunctionApr 8, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS RESCHEDULED. A TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A CE ROTABLATOR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DYNAGLIDE FOOT PEDAL WAS NOT WORKING. THE PROCEDURE WAS RESCHEDULED. THREE DAYS LATER, THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067270 ↗
• MalfunctionOct 27, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A CE ROTABLATOR ATHERECTOMY SYSTEMS AND DEVICES WAS SELECTED FOR USE. AFTER CONNECTING ALL THE CONNECTION WITH THE ROTA CONSOLE, IT WAS NOTED THAT THE FOOT PEDAL IN DYNAGLIDE MODE WAS NOT WORKING. THE CYLINDER PRESSURE WAS GOOD AND OTHER CONNECTION WAS ALSO FINE. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE ISSUE HAPPENED. THE PROCEDURE WAS RESCHEDULED AFTER 3 DAYS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15687551 ↗
• MalfunctionFeb 19, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED VESSEL. A DYNAGLIDE FOOT PEDAL WAS SELECTED FOR USE. AFTER THE PATIENT WAS SEDATED, IT WAS NOTED THAT THE FOOT PEDAL WAS NOT WORKING AS THE CONNECTER OF DYNAGLIDE WAS DAMAGED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS DISCHARGED WITHOUT PERFORMING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348942 ↗