ROTAPRO™ H749393002150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729893394), received between Sep 17, 2020 and Jun 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2021Entrapment of Device; Noise, Audible; Intermittent Loss of Power; Entrapment of Device; Noise, Audible; Intermittent Loss of Power

  IT IS REPORTED THAT A ROTAPRO AND ROTAWIRE ENTRAPMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS BEING PERFORMED. THE TARGET LESION WAS LOCATION IN THE 90% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. ROTABLATION WAS PERFORMED WITH A 1.75MM BURR ALONG WITH A ROTAWIRE THEY DECIDED TO SIZE UP TO A 2.15MM ROTAPRO. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT TO THE LESION BEFORE ABLATION. DURING REMOVAL WHILE IN DYNAGLIDE MODE THE BURR WAS UNABLE TO MOVE, THE CONSOLE STALL LIGHT WAS DISPLAYED AND A HIGH PITCHED SOUND HEARD. THE DEVICE WAS ABLE TO BE FORCEFULLY REMOVED AS A UNIT. ONCE THE DEVICE WAS OUTSIDE THE PATIENT THEY ATTEMPTED TO REMOVE THE DEVICE BUT IT WAS SEVERE AND DIFFICULT TO REMOVE. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995485 ↗
• MalfunctionNov 9, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING SEAL WAS TORN. A 2.15MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS FOUND THAT THE PACKAGING SEAL WAS TORN. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE EXTERNAL PACKAGING SEAL WAS TORN.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10809662 ↗
• MalfunctionSep 17, 2020Output Problem; Noise, Audible; Output Problem; Noise, Audible

  IT REPORTED THAT THERE WAS UNSTABLE SPEED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERIES. A 2.15MM ROTAPRO WAS SELECTED FOR USE AN PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE OF THE LAD ARTERIES. DURING THE PROCEDURE, THE DEVICE HAD AN ABNORMAL SOUND AND THE ROTATION SPEED WAS UNSTABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546767 ↗

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-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
• 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