ROTAPRO™ H749394672150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729999607), received between Nov 12, 2024 and Jan 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR DETACHED. A 2.15MM ROTAPRO BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR DETACHED. THE WIRE WAS PULLED AND REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266136 ↗
• MalfunctionNov 12, 2024Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT THERE WAS A HOLE ON THE SHAFT. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.15MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER CUTTING WITH THE ROTABURR, THE DRIVE SHAFT SHEATH WAS REMOVED AS USUAL OUTSIDE THE BODY, AND WHEN THE DRIVE SHAFT SHEATH WAS CHECKED, IT WAS FOUND THAT THERE WAS A HOLE IN THE DRIVE SHAFT SHEATH. THERE WAS ALSO AN UNUSUAL NOISE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665691 ↗

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