ROTAPRO™ H7493930901R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729975106), received between Aug 11, 2025 and Aug 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P900056); they may or may not involve this specific model.

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.

• MalfunctionAug 5, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146593 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS DISCOVERED THAT THE ELECTRICAL PORT WAS BROKEN. THE PROCEDURE WAS CANCELLED DUE TO THIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179144 ↗
• MalfunctionFeb 25, 2026Mechanics Altered

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. AT AN UNKNOWN TIME DURING THE EVENT, THE DEVICE WAS OBSERVED TO BE RUNNING AT A HIGHER RPM THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444665 ↗
• MalfunctionOct 22, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE ROTAPRO CONSOLE DISPLAY ISSUE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CONSOLE DISPLAY TURNED OFF AND FAILED TO COME BACK ON. THE POWER PLUG WAS MOVED TO ANOTHER OUTLET AND THE DISPLAY CAME BACK UP AND THE PROCEDURE WAS COMPLETED USING THIS CONSOLE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360461 ↗
• MalfunctionAug 11, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, ROTAPRO WILL NOT HOLD A STEADY RPM. THE ROTATIONS PER MINUTE ARE BOUNCING FROM 4K TO 100K AND ALL OVER THE PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota