ROTAPRO™ H749393002000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729893387), received between Dec 13, 2019 and Nov 17, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2022Entrapment of Device; Gas/Air Leak; Intermittent Loss of Power; Entrapment of Device; Gas/Air Leak; Intermittent Loss of Power

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A ROTAPRO 2.00MM AND ROTAWIRE WERE SELECTED TO TREAT A 99% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION WITHIN THE RIGHT CORONARY ARTERY (RCA). FOLLOWING A STALL OF THE BURR, UPON REMOVAL IT WAS NOTED THE ROTAPRO AND ROTAWIRE WERE STUCK TOGETHER AND WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819690 ↗
• MalfunctionJul 14, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTAPRO BURR BECAME STUCK ON THE ROTAWIRE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY (CX). A 2.00MM ROTAPRO CATHETER AND A ROTAWIRE WERE SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE ROTAPRO WAS PREPPED AND PLATFORMED AT 180,000RPM OUTSIDE THE PATIENT. THEN, THE BURR ADVANCED OVER THE WIRE, AND DYNAGLIDE MODE USED WHEN THE CATHETER WAS ADVANCED INTO THE LESION. AFTER TOTAL OF EIGHT ABLATIONS WERE PERFORMED SUCCESSFULLY, THE BURR BECAME STUCK ON THE ROTAWIRE. THE ROTAPRO AND THE ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT WITH A GUIDEZILLA GUIDE EXTENSION CATHETER SUPPORT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167306 ↗
• MalfunctionApr 30, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE IN SEVERELY CALCIFIED LESION. THE ROTAPRO WAS PREPPED AND PLATFORMED AT 180,000RPM OUTSIDE THE PATIENT, THEN ADVANCED OVER THE WIRE. DURING INSERTION, THE BURR BECAME STUCK ON THE WIRE INSIDE THE PATIENT. THE ROTAPRO AND THE ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752657 ↗
• MalfunctionNov 30, 2020Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE ROTAPRO BECAME STUCK ON THE ROTAWIRE AND WAS DIFFICULT TO REMOVE. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 75% STENOSED TARGET LESION WAS SEVERELY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. DURING THE PROCEDURE, AFTER PERFORMING ONE ABLATION RUN AT A ROTATION SPEED OF 180,000 RPMS, THERE WAS DIFFICULTY REMOVING THE DEVICE. THE ROTAPRO WAS REMOVED TOGETHER WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10924360 ↗
• InjurySep 10, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN THE LESION, AND THE SHAFT SEPARATED. A 2.0MM ROTAPRO WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ANATOMY WAS MODERATELY TORTUOUS WITH SEVERE CALCIFICATION AND 75% STENOSIS. THERE WAS DIFFICULTY DURING REMOVAL, AND THE DEVICE BECAME STUCK IN THE LESION. THE SHAFT SEPARATED AND WAS REMOVED USING THE MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT OF THE CATHETER WAS INTENTIONALLY CUT AND ANOTHER CATHETER WAS INSERTED TO REMOVE THE ROTAPRO FROM THE BODY. ROTABLATION WAS PERFORMED WITH A 1.75MM DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514370 ↗
• MalfunctionAug 31, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A 2.0MM ROTAPRO WAS SELECTED FOR USE. THE SET ROTATION SPEED WAS 180,000RPM. HOWEVER, ROTATION WAS UNSTABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474186 ↗
• MalfunctionJun 5, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A 2.0MM ROTAPRO CATHETER AND A ROTAWIRE GUIDEWIRE WERE SELECTED FOR AN ATHERECTOMY PROCEDURE. A 1.5MM DEVICE WAS INITIALLY USED AND THEN EXCHANGED FOR THE LARGER 2.0MM ROTAPRO CATHETER. WHEN ATTEMPTING WITHDRAWAL OF THE ROTAWIRE FROM THE CORONARY ARTERY, THE BURR BECAME STUCK ON THE WIRE. THE ROTAPRO AND ROTAWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10122926 ↗
• MalfunctionJan 6, 2020Detachment of Device or Device Component; Output Problem; Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT THE BURR TIP SEPARATED. A 2.00MM ROTAPRO WAS SELECTED FOR USE AN ATHERECTOMY PROCEDURE. DURING PREPARATION, THE ROTAPRO ADVANCER CONNECTED TO THE CONSOLE. WHEN THE ROTATION START BUTTON WAS MISTAKENLY PRESSED, THE BURR TIP GOT SEPARATED AND THE STALL INDICATOR DISPLAYED ON THE CONSOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553370 ↗
• MalfunctionDec 13, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK ON THE GUIDEWIRE. A 2.0MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR A MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY ATHERECTOMY PROCEDURE WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING WITHDRAWAL, THE BURR GOT STUCK ON THE WIRE. THE ROTAPRO AND ROTAWIRE WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9466035 ↗

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-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• 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