ROTAPRO™ H749394672000Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729999591), received between Nov 14, 2024 and May 20, 2026 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROTABURR WAS STUCK WITH THE ROTAWIRE. A 2.00MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. UPON REMOVAL FROM THE BODY AFTER ABLATION, THE ROTAPRO BECAME STUCK WITH THE ROTAWIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232035 ↗
• MalfunctionMay 13, 2026Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.0 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR CATHETER WAS ADVANCED UNDER DYNAGLIDE MODE NEAR THE TARGET LESION WITHOUT RESISTANCE. WHEN DYNAGLIDE MODE WAS DEACTIVATED TO INITIATE NORMAL ROTATIONAL OPERATION USING THE ADVANCER ON/OFF CONTROL FOR LESION TREATMENT, THE SYSTEM IMMEDIATELY EXHIBITED A STALL CONDITION. THE BURR STOPPED ROTATING AND BECAME STUCK, WITH NO FORWARD MOVEMENT POSSIBLE DESPITE APPROPRIATE MANIPULATION OF THE ADVANCER. THE DEVICE WAS WITHDRAWN AND REPLACED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162791 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT BURR ENTRAPMENT OCCURRED. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTATIONAL ATHERECTOMY FOR THE TREATMENT OF STENT DEFORMATION ASSOCIATED WITH CALCIFIED PLAQUES. 13 CONSECUTIVE PATIENTS PRESENTING WITH ANGINA PECTORIS SECONDARY TO STENT DEFORMATION CAUSED BY SEVERE CALCIFICATION WERE TREATED BETWEEN DECEMBER 2010 AND DECEMBER 2023. ROTATIONAL ATHERECTOMY WAS PERFORMED TO ABLATE BOTH THE DEFORMED STENT STRUTS AND THE UNDERLYING CALCIFIED PLAQUES. ALL PATIENTS RECEIVED ASPIRIN (100 MG), TICLOPIDINE HYDROCHLORIDE (200 MG), CLOPIDOGREL BISULFATE (75 MG), OR PRASUGREL HYDROCHLORIDE (3.75 MG) ORALLY. A 7F OR 8F ARTERIAL SHEATH WAS USED IN THE PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY (PTCRA) PROCEDURE. A TEMPORARY PACEMAKER WAS INSERTED TRANSFEMORALLY THROUGH A 6F SHEATH. A 0.009-INCH ROTAWIRE EXTRA SUPPORT GUIDEWIRE WITH A 0.014-INCH TIP (BOSTON SCIENTIFIC (BSC) WAS PASSED THROUGH THE LESION TO THE DISTAL CORONARY ARTERY. IN THE FIRST STEP, STENTABLATION WAS PERFORMED, IN WHICH A BURR OF THE OPTIMAL SIZE WAS USED TO ABLATE THE DEFORMED STENT STRUTS. IN THE SECOND STEP, THE BURR SIZE WAS INCREASED AS NEEDED TO AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045396 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT BURR ENTRAPMENT OCCURRED. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTATIONAL ATHERECTOMY FOR THE TREATMENT OF STENT DEFORMATION ASSOCIATED WITH CALCIFIED PLAQUES. 13 CONSECUTIVE PATIENTS PRESENTING WITH ANGINA PECTORIS SECONDARY TO STENT DEFORMATION CAUSED BY SEVERE CALCIFICATION WERE TREATED BETWEEN DECEMBER 2010 AND DECEMBER 2023. ROTATIONAL ATHERECTOMY WAS PERFORMED TO ABLATE BOTH THE DEFORMED STENT STRUTS AND THE UNDERLYING CALCIFIED PLAQUES. ALL PATIENTS RECEIVED ASPIRIN (100 MG), TICLOPIDINE HYDROCHLORIDE (200 MG), CLOPIDOGREL BISULFATE (75 MG), OR PRASUGREL HYDROCHLORIDE (3.75 MG) ORALLY. A 7F OR 8F ARTERIAL SHEATH WAS USED IN THE PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY (PTCRA) PROCEDURE. A TEMPORARY PACEMAKER WAS INSERTED TRANSFEMORALLY THROUGH A 6F SHEATH. A 0.009-INCH ROTAWIRE EXTRA SUPPORT GUIDEWIRE WITH A 0.014-INCH TIP (BOSTON SCIENTIFIC (BSC) WAS PASSED THROUGH THE LESION TO THE DISTAL CORONARY ARTERY. IN THE FIRST STEP, STENTABLATION WAS PERFORMED, IN WHICH A BURR OF THE OPTIMAL SIZE WAS USED TO ABLATE THE DEFORMED STENT STRUTS. IN THE SECOND STEP, THE BURR SIZE WAS INCREASED AS NEEDED TO AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045394 ↗
• MalfunctionFeb 6, 2026Entrapment of Device

  IT WAS REPORTED THAT THE ROTA BURR GOT STUCK WITH THE ROTA WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00 MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTA BURR GOT STUCK WITH THE ROTA WIRE INSIDE THE GUIDING CATHETER. THE BURR AND WIRE WERE REMOVED FROM THE BODY AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279806 ↗
• InjuryJan 7, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION REQUIRING ADDITIONAL DEVICE FOR REMOVAL. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING ADVANCEMENT TO THE TARGET LESION LOCATION, THE DEVICE GOT STUCK IN THE OSTIAL PART OF THE LEFT MAIN TRUNK. BAIL OUT USING A GUIDE EXTENSION CATHETER WAS REQUIRED FOR REMOVAL. THE PROCEDURE WAS COMPLETED WITH A SMALLER BURR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999820 ↗
• MalfunctionDec 16, 2025Nonstandard Device; Material Separation; Nonstandard Device; Material Separation

  IT WAS REPORTED THAT THE BURR GOT DETACHED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX OSTIUM. A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED WAS SET TO 180,000 RPM. WHEN THE THIRD DEBULKING PERFORMED, IT WAS NOTED THAT THE ROTATING BURR DID NOT MOVE AND GOT SEPARATED. SINCE THE DETACHED BURR WAS ON THE ROTAWIRE DRIVE, IT WAS SIMPLY REMOVED OUTSIDE THE BODY ALONG WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820690 ↗
• MalfunctionNov 20, 2025Entrapment of Device; Nonstandard Device; Intermittent Loss of Power; Entrapment of Device; Nonstandard Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTAPRO WAS SELECTED FOR USE AND SPEED WAS SET AT 180,000 RPM. AFTER 2 ABLATIONS, THE DEVICE STALLED AND THE BURR BECAME STUCK WITHIN THE LESION. THE PROXIMAL PART OF THE DRIVE SHAFT WAS CUT AND THE DEVICE WAS RELEASED BY UTILIZING THE GUIDE CATHETER TO PRESS ON THE AREA WHERE THE BURR WAS STUCK. THE BURR AND GUIDEWIRE WERE THEN REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607535 ↗
• MalfunctionOct 21, 2025Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT BRAKE FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BURR WAS ADVANCED IN DYNAGLIDE MODE, AND AN ATTEMPT WAS MADE TO START AT 180,000 RPM, BUT BRAKE FAILURE HAS OCCURRED AND THE ROTAWIRE CAME OUT FROM THE INSERTED POSITION. IT WAS TRIED THREE TIMES, BUT THE SITUATION WAS THE SAME, SO THE ADVANCER WAS REPLACED. THE DEVICE WAS REMOVED NORMALLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351077 ↗
• MalfunctionOct 16, 2025Entrapment of Device; Nonstandard Device; Material Separation; Detachment of Device or Device Component; Device-Device Incompatibility; Mechanical Jam; Entrapment of Device; Nonstandard Device; Material Separation; Detachment of Device or Device Component; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE BURR GOT STUCK AND SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 1.50MM ROTAPRO AND 2.0MM ROTAPRO WERE SELECTED FOR USE. DURING THE PROCEDURE, WITH DOCTOR AOYAMA, A 1.5MM ROTAPRO WAS ADVANCE AT 180,000RPM. HOWEVER, UPON FIVE SESSIONS, THE SPEED HAS REDUCED TO 2,000RPM AND THE ADVANCER MOVE ALL THE WAY TO THE RIGHT AND STOPPED WITHIN THE CALCIFIED AREA WITHOUT COMPLETELY CROSSING THE LESION WITH THE SPEED CONTINUOUSLY DROPPING. THE DEVICE WAS PULLED GENTLY ON THE PROXIMAL PART UP TO THE GUIDE, BUT RESISTANCE WAS FELT UPON INSERTION. IMAGING SHOWS THE BURR REMAINED AND GOT SEPARATED. SINCE THE WIRE WAS NOT CUT, THE DEVICE WAS REMOVED BY SIMPLY PULLING THE WIRE OUT. DOCTOR (B)(6) CHANGED THE BURR SIZE TO 2.0MM ROTAPRO AND WAS ADVANCED TO 180,000RPM UNTIL SEVEN SESSION AND LOWER DOWN TO 6,000RPM. UPON INCREASING THE ABLATION, THE BURR GOT COMPLETELY STRUCK AT THE STENOSIS SITE AFTER 1,000RPM DROP. SINCE THIS PART WAS NEAR THE OSTIUM PART, THE BURR WAS PULLED PROXIMALLY AT THE SAME TIME WITH THE GUIDE. HOWEVER, A SEVERE RESISTANCE WAS FELT WHEN PULLED WITHIN THE GUIDE AND GOT SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310863 ↗
• InjurySep 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE WIRE GOT SEPARATED. A 1.50MM ROTAPRO, 2.00MM ROTAPRO AND TWO NG ROTAWIRE FLOPPY 5 PACK WERE SELECTED FOR USE. DURING REMOVAL USING DYNAGLIDE, THE ADVANCER AND THE WIRE BECAME STUCK MIDWAY AND THEN WERE REMOVED TOGETHER. AN ADDITIONAL ABLATION WAS PERFORMED WITH A SECOND BURR AND ROTAWIRE. WHEN ATTEMPTING TO REMOVE THE WIRE, THE ROTAWIRE CAME OUT, LIKELY CAUSING A RUPTURE OF THE OPAQUE PORTION OF THE ROTAWIRE DUE TO CONTACT WITH THE BURR. IT HAD TO COME OUT TO THE PROXIMAL AREA, SO IT COULD BE EASILY REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137461 ↗
• InjurySep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR GOT DETACHED. A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER CUTTING THE SHAFT, IT WAS ATTEMPTED TO REMOVE THE STUCK DEVICE BY BRINGING IN A GUIDE EXTENSION, BUT ONLY THE SHAFT CAME OUT. CONSEQUENTLY, DURING DEBULKING OF THE RIGHT SHOULDER REGION, THE BURR WAS FOUND DETACHED WHICH WAS LIKELY DUE TO HINGE MOTION. THE BURR WAS RETRIEVED ALONG WITH THE ROTA WIRE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062621 ↗
• MalfunctionSep 15, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 2.00 ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED WAS UNSTABLE. SET ROTATION SPEED WAS 190K RPM, AND MAXIMUM SPEED REACHED WAS 200K RPM. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057717 ↗
• InjurySep 3, 2025Entrapment of Device; Nonstandard Device; Intermittent Loss of Power; Entrapment of Device; Nonstandard Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED WAS SET AT 210,000RPM. DYNAGLIDE MODE WAS USED WHILE ADVANCING THE BURR TO THE LESION. THEN, IT WAS NOTED THAT THE ROTABURR STALLED AND WAS STUCK IN THE LESION. THE DEVICE WAS UNSTUCK BY CROSSING THE WIRE THROUGH THE LUMEN AND USE INTRAVASCULAR LITHOTRIPSY (IVL) TO BREAK THE CALCIFICATION AND RELEASE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952668 ↗
• MalfunctionJun 17, 2025Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT ROTABURR GOT STUCK ON THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A ROTAWIRE AND 2.00MM ROTAPRO WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATIONAL SPEED WAS SET TO 180,000 RPM WITH A MAXIMUM OBSERVED SPEED OF 190,000 RPM. UPON INSERTION, THE WIRE GOT STUCK WITH THE BURR AND COULD NOT BE UNSTUCK. THE ROTABURR AND WIRE WERE REMOVED TOGETHER AS ONE UNIT. WHEN THE DEVICE WAS REMOVED, THE WIRE WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233379 ↗
• MalfunctionJun 6, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. A 2.00MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING REMOVAL, THE BURR GOT STUCK WITH THE ROTAWIRE. THE BURR AND WIRE WERE REMOVED AS ONE UNIT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159697 ↗
• MalfunctionMay 7, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 2.00MM ROTAPRO AND ROTAWIRE WERE USED FOR THE PROCEDURE. DURING THE PROCEDURE, UPON INSERTION WITH A SET ROTATION SPEED OF 180,000 RPM, IT WAS NOTED THAT THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. THE ROTAPRO BURR WAS REMOVED ALONG WITH THE ROTAWIRE AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976372 ↗
• MalfunctionJan 30, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTA BURR WAS STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, UPON REMOVAL, THE ROTA BURR GOT STUCK WITH THE ROTAWIRE. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277625 ↗
• MalfunctionDec 11, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK WITH THE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED FIRST RIGHT POSTEROLATERAL SEGMENT. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, UPON WITHDRAWAL, IT WAS NOTED THAT THE BURR STUCK WITH THE WIRE. THE DEVICE WAS REMOVED AS ONE UNIT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903442 ↗
• MalfunctionDec 9, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTAPRO BECAME STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO WAS SET AT A MAXIMUM SPEED OF 180,000RPM; HOWEVER, THE ROTAPRO BECAME STUCK WITH THE ROTAWIRE. THE DEVICES COULD NOT BE RELEASED, AND WERE REMOVED AS ONE UNIT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884399 ↗
• MalfunctionNov 26, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.00 MM ROTAPRO, ROTAWIRE DRIVE AND A 15 MM X 4.00 MM WOLVERINE CORONARY CUTTING BALLOON WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WOLVERINE WAS UNABLE TO CROSS THE LESION. THE ROTAPRO WAS ALSO NOTED TO BE STUCK WITH THE WIRE JUST BEFORE THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786348 ↗
• InjuryNov 15, 2024Difficult or Delayed Activation; Material Integrity Problem; Difficult or Delayed Activation; Material Integrity Problem

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. A 1.75MM ROTAPRO, 2.00MM ROTAPRO AND A ROTAPRO CONSOLE WERE SELECTED FOR USE. DURING THE PREPARATION, THE 2.00MM BURR WOULD NOT TURN ON. THE GAS AND CONNECTION WERE CHECKED. THEN USED A 1.75MM BURR, BUT THE ISSUE PERSISTED. THE PHYSICIAN COMMENTED THAT THE PATIENT ACQUIRED A THROMBOSIS WHILE TROUBLESHOOTING THE DEVICE. THEY HAD TO DO THROMBECTOMY WITH PENUMBRA. THE PROCEDURE WAS COMPLETED WITH ANOTHER BURR. UPON INVESTIGATION IT APPEARED THAT THE CONSOLE ELECTRICAL PIECE NO LONGER ALIGNED TO ALLOW CONNECTION BETWEEN BURR AND THE CONSOLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND EXPECTED PATIENT TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20695699 ↗
• MalfunctionNov 14, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE ROTATION SPEED WAS UNSTABLE. A 2.00MM ROTAPRO WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE SPEED WAS UNSTABLE AS IT INCREASES AND DECREASES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683792 ↗

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-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