ROTAPRO™ H749394671250Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 08714729999560), received between Mar 10, 2021 and Sep 29, 2026 — classified as 3 deaths, 14 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (29 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Entrapment of Device; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938888 ↗
• InjurySep 11, 2026Failure to Advance; Device Damaged by Another Device; Output Problem

  It was reported that the wire detached and a perforation occurred requiring additional surgery.The 15mm long and 95% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery with a vessel diameter of 3.0 mm. A 1.25mm Rotapro and Rotawire Drive were selected for use. During the procedure, difficulty crossing the lesion was experienced. Seventeen ablations were performed at a set speed of 190,000 rpm for 15 seconds each. The physician noted reductions in speed ranging from 2,000 to 10,000 rpm during ablation. A perforation was observed on the opposite side of the calcified nodule and upon withdrawal of the devices it was noted that the RotaWire had separated a few centimeters proximal to the radiopaque marker. It was considered possible that the separation was due to burr contact. Bypass grafting of the proximal LAD was performed to treat the perforation. No device fragments were left inside the body. Following surgery, the patient was weaned from mechanical ventilation, resumed oral intake, and is currently undergoing rehabilitation.

  Patient problems: Perforation

  MAUDE report 50735305 ↗
• MalfunctionAug 7, 2026Failure to Advance; Intermittent Loss of Power

  It was reported that the procedure was aborted. The 99% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery. A 1.25mm Rotapro was selected for use. During procedure, inspite of repeated pre-dilation, advancing difficulties was experienced at the lesion location and repeat stall indication was observed. Hence, the procedure was aborted and sent for CABG. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181200 ↗
• MalfunctionAug 4, 2026Entrapment of Device; Nonstandard Device; Noise, Audible; Material Split, Cut or Torn; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 50129507 ↗
• MalfunctionAug 3, 2026Entrapment of Device; Nonstandard Device; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122035 ↗
• MalfunctionJul 31, 2026Fluid/Blood Leak; Mechanical Jam; Material Split, Cut or Torn

  It was reported that a hole/leak issue occurred.A ROTAPRO 1.25mm was selected for treatment of the target lesion that was 70% stenosed. During the procedure, it was noted that there was difficulty putting the wire in the burr and a saline leak/hole was noted near the burr tip. The leak/hole was located on a portion of the device that would enter the patient. The device was outside of the patient when the leak/hole was discovered. 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 50098028 ↗
• MalfunctionJul 30, 2026Material Separation

  It was reported that the burr tip got fractured.The target lesion was located in the left anterior descending branch. A 1.25mm ROTAPRO was selected for use. During the procedure, the burr catheter tip was fractured. The procedure was completed with another of same device. There were no complications reported, and patient is stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50088812 ↗
• InjuryJul 30, 2026Nonstandard Device; Material Separation; Output Problem

  It was reported that the burr detached requiring additional intervention.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery. A 1.25mm RotaPro was selected for use. During the procedure, the rotational speed dropped from the set speed of 220,000 rpm and the tip of the burr separated in the lesion site. Snaring was done to remove the fragment. The procedure was completed with a different device. There were no complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085276 ↗
• MalfunctionJul 17, 2026Failure to Advance; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2026. IT WAS REPORTED THAT DEVICE FAILED TO REACH OPTIMUM SPEED DURING PROCEDURE. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.25MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR DROPPED PRESSURES MULTIPLE TIMES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT FULLY RECOVERED AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864009 ↗
• MalfunctionJul 9, 2026Nonstandard Device; Output Problem; Noise, Audible; Intermittent Loss of Power

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A 1.25MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, A ROTAPRO WAS USED TO TREAT A CORONARY ARTERY. THE SPEED WAS SET AT 200,000 RPM, BUT RPMS FLUCTUATED SIGNIFICANTLY BETWEEN 125,000 RPM AND 230,000 RPM IN NORMAL MODE. THE DEVICE WAS ALSO MAKING A HIGH-PITCHED NOISE. TWO LESIONS WERE TREATED; HOWEVER, THE SYSTEM DID EVENTUALLY STALL. THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774277 ↗
• MalfunctionJun 17, 2026Nonstandard Device; Material Separation

  IT WAS REPORTED THAT BURR DETACHMENT OCCURRED. A 1.35MM ROTAPRO WAS SELECTED FOR USE. DURING PROCEDURE, THE BURR DISCONNECTED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541732 ↗
• MalfunctionMay 21, 2026Mechanical Problem

  IT WAS REPORTED THAT WIRE MOVEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 1.25MM ROTAPRO WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE WIRE MOVED WHILE MOVING ADVANCER KNOB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED VIA ANOTHER METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246655 ↗
• InjuryApr 27, 2026Nonstandard Device; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK AND DIFFICULTY REMOVAL OCCURRED. THE GREATER THAN 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND TORTUOUS VESSEL WITH AN EXISTING STENT THAT HAD BEEN DEPLOYED AT ANOTHER HOSPITAL LESS THAN THREE MONTHS PRIOR. DURING THE PROCEDURE, THE BURR WAS OPERATING AT APPROXIMATELY 160 RPM. HOWEVER, WHILE ATTEMPTING TO BURR THE CALCIUM AT THE EDGE OF THE STENT, THE BURR BECAME STUCK AFTER GRABBING POSSIBLE STENT STRUTS, ALTHOUGH THE CONSOLE DID NOT STALL AND CONTINUED TO SPIN. THE BURR WAS ABLE TO ADVANCE BUT COULD NOT BE WITHDRAWN. AN INCREASE IN BURR SPEED TO ABOVE 200 RPM WAS PERFORMED, AND AN ADDITIONAL GUIDE WAS PLACED WITH A WIRE ADVANCED DOWN THE VESSEL. A 2.0 BALLOON WAS DEPLOYED NEXT TO THE STUCK BURR, AND WITH COMBINED BALLOONING AND INCREASED BURR SPEED, THE BURR WAS SUCCESSFULLY BROUGHT BACK INTO THE GUIDE AND MANUALLY REMOVED IN ONE PIECE WITHOUT THE USE OF DYNAGLIDE. THE PROCEDURE WAS THEN COMPLETED WITH MULTIPLE ANGIOPLASTIES AND DEPLOYMENT OF A NEW DES. THERE WERE NO PATIENT COMPLICATIONS, THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002422 ↗
• DeathApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.25 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE AORTA WAS DISSECTED. CARDIOTHORACIC SURGERY WAS PERFORMED TO TREAT THE DISSECTION; HOWEVER, PATIENT DIED AFTER GOING TO SURGERY.

  Patient problems: Aortic dissection

  MAUDE report 24980350 ↗
• MalfunctionApr 20, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE 10MM LONG AND 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA) WITH A VESSEL DIAMETER OF 3.00 MM. A 1.25MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE GOT STUCK IN THE BURR CATHETER. 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 24931823 ↗
• DeathApr 3, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DIED. A 1.25MM ROTAPRO WAS TREATMENT OF A HEAVILY CALFICIED CORONARY ARTERY. DURING PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK IN THE LESION. REMOVAL OF THE BURR WAS ATTEMPTED FOR SEVERAL MINUTES WITHOUT SUCCESS. A BALLOON WAS USED TO TRY TO DILATE THE CORONARY ARTERY AND REMOVE THE BURR, AND A GUIDELINE WAS ADVANCED FOR ADDITIONAL SUPPORT WITHOUT SUCCESS. THE PATIENT CONDITION CONTINUED TO DETERIORATE, AND THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776406 ↗
• MalfunctionMar 23, 2026Nonstandard Device; Material Separation; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE BURR CATHETER FRACTURED. A ROTAPRO 1.25MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE PLASTIC PART OF THE CATHETER BECAME DETACHED. ANOTHER BURR WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664556 ↗
• MalfunctionMar 23, 2026Entrapment of Device; Nonstandard Device; Difficult to Remove; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK ONTO THE GUIDEWIRE AND DIFFICULTY REMOVAL OCCURRED. A 1.25MM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR STALLED AND COULD NOT BE REMOVED, AS IT FELT LIKE IT WAS STUCK ON THE GUIDEWIRE RATHER THAN IN THE STENOSIS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664553 ↗
• MalfunctionMar 20, 2026Entrapment of Device

  IT WAIT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. A ROTAPRO 1.25MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. AFTER INTRODUCING THE BURR TO THE TARGET LESION, THE PHYSICIAN NOTICED A STUCK INDICATION. THEY REMOVED THE DEVICE FROM THE PATIENT AND USED ANOTHER OF THE SAME DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650620 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT DEVICE PERFORATION OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 1.25MM ROTAPRO WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT WATER WAS SPRAYING FROM A PERFORATION IN THE DEVICE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547097 ↗
• MalfunctionMar 2, 2026Nonstandard Device; Difficult to Remove; Output Problem; Noise, Audible; Material Split, Cut or Torn

  IT WAS REPORTED THAT A DEVICE REMOVAL DIFFICULTY AND SHEATH DAMAGE OCCURRED. A 1.25 MM ROTAPRO WAS SELECTED FOR THE ROTABLATION PROCEDURE. DURING WITHDRAWAL IN DYNAGLIDE MODE, THE PHYSICIAN ENCOUNTERED RESISTANCE ACCOMPANIED BY A HIGH-PITCHED SOUND, A SUDDEN RISE IN ROTATIONAL SPEED. AFTER THE ROTAPRO SYSTEM WAS REMOVED, A PORTION OF THE SHEATH APPEARED TO HAVE PERISHED OR BURNED AWAY. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491420 ↗
• MalfunctionFeb 25, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT A WIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WITH ABOUT 22MM LESION LENGTH AND 2.0MM TO 2.25MM TARGET VESSEL DIAMETER WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED OSTIUM OF CIRCUMFLEX ARTERY. A ROTAWIRE FLOPPY 5 PACK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE WIRE FRACTURED AT THE DISTAL CIRCUMFLEX WHILE PERFORMING ABLATION WITH A 1.25 MM BURR DISTAL TO A 90 DEGREES BEND. THE FRACTURED WIRE WAS LEFT IN PLACE, AND THE ABLATION WAS CONTINUED WITH A 1.75MM BURR AND A SECOND WIRE. DURING ABLATION, THE SECOND WIRE BECAME ENTANGLED WITH THE RETAINED FIRST WIRE AND FRACTURED. THE TWO ENTANGLED WIRES WERE SECURELY COMPRESSED AGAINST THE VESSEL WALL WITH A STENT AND THE REMAINING FRAGMENTS OF BOTH FRACTURED WIRES WERE RETRIEVED NORMALLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445504 ↗
• InjuryFeb 23, 2026Entrapment of Device; Nonstandard Device; Difficult to Remove; Material Separation; Intermittent Loss of Power

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT. A PATIENT PRESENTED A 2.5MM IN DIAMETER TOTAL CHRONIC OCCLUSION IN THE SEVERELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 1.25MM ROTAPRO AND ROTAWIRE DRIVE WERE ADVANCED WITH NO RESISTANCE BEING ENCOUNTERED. THE LESION WAS ABLATED ONCE AT 180,000 RPM FOR 10 SECONDS. THE ROTATION SPEED WAS EXTREMELY LOW, AND THE STALL LAMP WAS LIT. THERE WAS SEVERE RESISTANCE AND THE ROTAPRO WAS STUCK AT THE LESION. AFTER THE DRIVE SHAFT WAS CUT AT ITS BASE, AN ATTEMPT WAS MADE TO REMOVE THE DEVICE FROM THE LESION. DURING THIS PROCESS, THE DRIVE SHAFT SEPARATED ON THE PROXIMAL SIDE OF THE BUTT, AND THE BURR TIP REMAINED INSIDE THE PATIENT. A GUIDE EXTENSION CATHETER, A GUIDE WIRE, AND A BALLOON CATHETER WERE USED DURING A BAILOUT ATTEMPT TO REMOVE THE DEVICE FRAGMENT. THE FRAGMENT COULD NOT BE REMOVED, AND THE PROCEDURE WAS COMPLETED BY STENTING THE REMAINING PART. THERE ARE NO PLANS FOR FURTHER TREATMENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN VERY GOOD CONDITION POST PROCEDURE. IT WAS REPORTED THAT BOTH THE DRIVE SHAFT AND OUTER SHEATH WERE CUT WITH SCISSORS NEAR THE RECOMMENDED LENGT

  Patient problems: Foreign Body In Patient

  MAUDE report 24421476 ↗
• MalfunctionFeb 23, 2026Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05FEB2026. IT WAS REPORTED THAT DEVICE FAILED TO REACH OPTIMUM SPEED. THE PATIENT WAS BEING TREATED FOR CHEST PAIN. A 1.25MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION, BURR WAS UNABLE TO INCREASE SPEED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413282 ↗
• MalfunctionFeb 17, 2026Nonstandard Device; Self-Activation or Keying; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT AN UNINTENTIONAL SWITCH TO DYNAGLIDE MODE OCCURRED. A 1.25 MM ROTAPRO BURR WAS SELECTED FOR THE PROCEDURE. DURING ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE DEVICE UNINTENTIONALLY SWITCHED TO DYNAGLIDE MODE. THE MODE DID NOT DEACTIVATE AUTOMATICALLY WHEN PRESSING THE DYNAGLIDE MODE BUTTON. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366768 ↗

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