ROTAPRO™ H749394671750Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08714729999584), received between Nov 15, 2024 and Sep 25, 2026 — classified as 1 death, 10 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (19 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Entrapment of Device; Output Problem; Intermittent Loss of Power

  Patient problems: Bradycardia; Ischemia; Non specific EKG/ECG Changes; Vascular Dissection

  MAUDE report 50903205 ↗
• MalfunctionSep 14, 2026Entrapment of Device; Noise, Audible; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763518 ↗
• MalfunctionSep 10, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725099 ↗
• MalfunctionSep 2, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572012 ↗
• MalfunctionSep 2, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572011 ↗
• MalfunctionSep 2, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569934 ↗
• MalfunctionSep 1, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550389 ↗
• MalfunctionJul 30, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085705 ↗
• MalfunctionJul 20, 2026Mechanical Problem; Nonstandard Device; Output Problem; Noise, Audible

  IT WAS REPORTED THAT A BRAKE ISSUE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATION IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON ABLATION AT A SET SPEED OF 180,000 RPM, A STRANGE CONTINUOUS LOW CUTTING SOUND WAS NOTED. THE WIRE FIXATION WAS INSUFFICIENT AND FELT LESS SECURE WITH SLIGHT RESISTANCE. DURING WITHDRAWAL, THE DYNAGLIDE WAS ROTATING AT HIGHER SPEED OF 150,000 RPM DUE TO A CONSOLE ISSUE. THE PROCEDURE CONTINUED WITHOUT USE OF DYNAGLIDE MODE AND THE BURR AND WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876858 ↗
• MalfunctionJul 9, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE ROTA BURR GOT STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE BURR GOT STUCK WITH THE ROTAWIRE. THE DEVICES WERE REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774271 ↗
• MalfunctionJul 1, 2026Entrapment of Device; Output Problem

  IT WAS REPORTED THAT BURR STUCK ON WIRE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID-PROXIMAL RIGHT CORONARY ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE WAS SELECTED FOR USE. DURING INSERTION INSIDE THE PATIENT, SPEED REACHED 185,000 RPM DESPITE A SETTING OF 190,000 RPM. IT WAS NOTED THAT THE ROTA BURR GOT STUCK WITH THE ROTAWIRE AND WAS UNABLE TO RELEASED. THE DEVICES WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682419 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 1.75MM ROTAPRO WAS SELECTED FOR TREATMENT OF A TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, A FLOW LIMITING DISSECTION WAS NOTED IN THE LEFT MAIN (LM) AND THE PATIENT WENT INTO CARDIAC ARREST. BALLOONING AND STENTING OF THE PROXIMAL LAD AND PROXIMAL LM WAS REQUIRED AND THE PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED AND WAS STABLE POST PROCEDURE.

  Patient problems: Cardiac Arrest; Reduced Blood Flow; Vascular Dissection

  MAUDE report 25627586 ↗
• MalfunctionJun 25, 2026Nonstandard Device; Device Remains Activated; Output Problem; Activation Problem

  IT WAS REPORTED THAT A FAILURE TO STOP ROTATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.75 MM ROTAPRO BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS ROTATING INSIDE THE PATIENT AT THE LESION AND COULD NOT BE STOPPED. THE BURR DID NOT TURN OFF DESPITE MULTIPLE ATTEMPTS, AND IT BRIEFLY TURNED ITSELF BACK ON TWICE WITH NO ONE NEAR THE BUTTONS. THE DEVICE WAS SET AT 180,000 RPM IN NORMAL MODE. THE DEVICE WAS REMOVED WITHOUT USING DYNAGLIDE. WHEN IT WOULD NOT TURN OFF, IT WAS UNPLUGGED AND SAFELY REMOVED FROM THE BODY WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621280 ↗
• MalfunctionJun 16, 2026Device Damaged by Another Device; Noise, Audible

  IT WAS REPORTED THAT GUIDEWIRE SEPARATION OCCURRED WITH A RETAINED FRAGMENT AND PROCEDURE WAS CANCELLED. THE 30 MM LONG AND 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH A VESSEL DIAMETER OF 3.00- 3.40 MM. A ROTAWIRE AND 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AND AN UNUSUAL SOUND WAS HEARD. THE GUIDEWIRE DETACHED 5 CM FROM THE TIP DUE TO CONTACT WITH THE BURR. PER THE PHYSICIAN. THE WIRE MAY HAVE BEEN KINKED. ATTEMPTS TO RETRIEVE THE DEVICE FRAGMENT WITH A NON-BOSTON SCIENTIFIC BALLOONS, GUIDE EXTENSION CATHETER AND GUIDEWIRE WERE UNSUCCESSFUL. THE DETACHED DEVICE SEGMENT REMAINED INSIDE THE PATIENT AND THE PROCEDURE WAS CANCELLED AS THERE WERE NO ADDITIONAL DEVICES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519720 ↗
• MalfunctionMay 1, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.75MM ROTAPRO AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING INSERTION, THE ROTABURR BECAME STUCK ON THE ROTAWIRE AND COULD NOT BE RELEASED FROM BEING STUCK. THE ROTABURR WAS REMOVED TOGETHER WITH THE ROTAWIRE FROM THE BODY AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058340 ↗
• MalfunctionMay 1, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT A GUIDEWIRE MOVEMENT ISSUE OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN FOR A PERCUTANEOUS CORONARY INTERVENTION. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING DELIVERY UNDER DYNAGLIDE MODE, THE WIRE WAS MOVING OUTWARDS. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057717 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak; Nonstandard Device; Failure to Advance

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING FLUID. A 1.75 MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION, SALINE FLUSH WAS LEAKING FROM IN FRONT OF THE DRILL. DIFFICULTY WAS EXPERIENCED ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913643 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT A LEAK OCCURRED. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SALINE COCKTAIL SOLUTION WAS LEAKING FROM THE OUTER SHEATH INSIDE OF THE GUIDE CATHETER. A HOLE WAS NOTED IN THE DEVICE. THE ROTAPRO WAS REMOVED AND THE PROCEDURE WAS COMPETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899167 ↗
• MalfunctionApr 7, 2026Nonstandard Device; Improper Flow or Infusion; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT BLOOD FLOWS BACK FROM THE TIP. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CORONARY ARTERY (LCA). A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING ROTATION SPEED ADJUSTMENT AND ABLATION, THE STALL LAMP ILLUMINATES. THE ROTA COCKTAIL FLOWS AT AN ABNORMALLY RAPID RATE. BLOOD FLOWS BACK FROM THE TIP. THE TARGET SPEED WAS AT 180,000 AND THE ACTUAL SPEED WAS AT 60,000 TO 90,000 RPM DURING NORMAL AND DYNAGLIDE MODE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801148 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  IT WAS REPORTED A FLUID LEAK OCCURRED. A ROTAPRO 1.75MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION WHICH WAS SEVERELY TORTUOUS AND 60% STENOSED. DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTICED A HOLE WHERE SALINE WAS LEAKING OUT NEAR THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS REPLACED AND ANOTHER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770234 ↗
• MalfunctionMar 12, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK ON GUIDEWIRE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS BUT SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING INSERTION INTO THE PATIENT'S BODY, IT WAS NOTED THAT THE ROTABURR GOT STUCK ON THE ROTAWIRE. THE DEVICES WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579727 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A SHAFT HOLE OCCURRED. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION PRIOR TO USE, IT WAS NOTED THAT THE TIP OF THE ROTA BURR HAD A HOLE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457280 ↗
• MalfunctionFeb 25, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 22 MM LONG, 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS OSTIAL CIRCUMFLEX WITH A DIAMETER OF 2.0 TO 2.25 MM. A 1.25 MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. AFTER THE THIRD ABLATION AT 180,000 RPM DISTAL TO A 90 DEGREE BEND, THE ROTAWIRE DETACHED DUE TO CONTACT WITH THE BURR. THE DETACHED WIRE WAS LEFT IN PLACE AND A 1.75MM ROTAPRO AND ADDITIONAL ROTAWIRE WERE INTRODUCED TO CONTINUE TREATMENT. AFTER THREE ABLATIONS AT 180,000 RPM, THE GUIDEWIRES BECAME ENTANGLED AND THE SECOND WIRE DETACHED. PER THE PHYSICIAN, THE SECOND WIRE DETACHMENT WAS ALSO CONSIDERED TO BE DUE TO CONTACT WITH THE BURR. THE ENTANGLED WIRES WERE SECURELY COMPRESSED AGAINST THE VESSEL WALL WITH A NON-BOSTON SCIENTIFIC STENT AND THE REMAINING FRAGMENTS WERE RETRIEVED VIA THE NORMAL METHOD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445507 ↗
• MalfunctionFeb 9, 2026Nonstandard Device; Output Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE DEVICE COULD NOT SWITCH BETWEEN HIGH AND LOW SPEED. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292513 ↗
• MalfunctionFeb 5, 2026Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A ROTAPRO 1.75MM WAS SELECTED FOR USE. DURING ROTATION IN THE HIGH-SPEED MODE, IT WAS NOTED THAT ALTHOUGH THE SET ROTATIONAL SPEED WAS 140,000, THE MAXIMUM ROTATIONAL SPEED WAS FOUND TO BE 160,000 RPM. ADDITIONALLY, IT WAS NOTED THAT DURING ROTATIONAL GRINDING A STALL OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268981 ↗

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