RotaWire™ Drive and wireClip™ Torquer H74939462001Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 08714729996255), received between Nov 18, 2024 and Sep 15, 2026 — classified as 3 deaths, 32 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (49 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Mar 8, 2022Class IIOpen, Classified

   Pouch seals may be open, compromising sterility.

   Z-0915-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Entrapment of Device

  It was reported that the burr and wire became stuck.A 1.50mm Rotapro and a RotaWire Drive were selected for use. During the procedure, it was noted that the burr and wire became stuck. The Rotawire and burr were removed together from the patient as a single unit. The procedure was completed with another burr and another wire. There were no patient complications, and the patient was in good condition after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773482 ↗
• InjurySep 14, 2026Detachment of Device or Device Component; Difficult to Advance

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 50763664 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  It was reported that a distal tip detachment occurred.The target lesion was located in the severely calcified artery. A ROTAWIRE Drive was selected for use. During the procedure, it was noted that a portion of the radiopaque marker area appeared to be missing and was described as an area that was not a radiopaque marker. The device was completely removed from the patient without any issues. The procedure was successfully 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 50692012 ↗
• MalfunctionSep 8, 2026Nonstandard Device; Deformation Due to Compressive Stress

  Reportable based on device analysis completed on 13AUG2026.It was reported that the wire was kinked.A Rotawire Drive was selected for use. During unpacking, it was noted that the wire was kinked. A second wire was opened and the same thing occurred. A third wire with a different lot number was able to complete the procedure. There were no patient complications.However, device analysis revealed that the spring tip was detached and did not return for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674414 ↗
• MalfunctionSep 8, 2026Entrapment of Device

  It was reported that the burr became stuck on the guidewire.The 90% stenosed target lesion was located in the severely calcified left anterior descending (LAD) artery. A 1.50mm RotaPro and ROTAWIRE Drive were selected for use. The ROTAWIRE was crossed into the LAD and placed across the lesion. When the burr was advanced, it failed to advance on the wire beyond a certain point just proximal to the non-Boston Scientific guide catheter. When the physician attempted to withdraw the catheter, it would not move. The wire was hydrated, and the RotaPro was pulled with force; but could not be withdrawn. Due to the inability to either withdraw or advance the burr, the entire assembly was withdrawn. The procedure was completed using alternate devices. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672436 ↗
• InjurySep 8, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that a detachment occurred resulting in a retained device fragment. The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified circumflex (Cx) artery. A 1.25mm Rotapro and a RotaWire Drive were selected for use. During the procedure, the wire was placed across the mid Cx vessel but could not be delivered distally. Ablation was performed at 172,000rpm and the burr successfully crossed the calcified portion of the lesion. Dynaglide mode was then activated to retract the burr from the vessel. During removal, the distal tip of the RotaWire separated due to burr contact with the distal portion of the wire. The burr and proximal portion of the RotaWire were successfully removed from the patient; however, a short distal wire fragment remained within the vessel. Echo was performed and no pericardial effusion was found. A stent was placed over the wire fragment anchoring it to the vessel wall. The procedure was completed and the patient was stable post procedure.It was further reported that no attempts were performed to retrieve the fragment and that the procedure was completed with the original device.

  Patient problems: Foreign Body In Patient

  MAUDE report 50671211 ↗
• InjurySep 2, 2026Difficult to Remove; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568645 ↗
• InjurySep 2, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that guidewire detached. The patient presented with a chronic total occlusion in the right coronary artery. A Rotawire Drive was selected for use. During procedure, after the guidewire was successfully advanced, the device could not be passed through. Following standard protocol, the rotational atherectomy system was deployed without a guidewire, and treatment was performed using a 1.25 mm burr. The Rotawire was found to have fractured. A post-procedure measurement of the involved length and CT scan indicated that the wire had fractured within the coronary artery. Physician recommended a surgical bypass followed by repeat percutaneous intervention, but the patient refused and requested conservative treatment. The patient currently has no symptoms and has been discharged.

  Patient problems: Foreign Body In Patient

  MAUDE report 50568430 ↗
• MalfunctionSep 1, 2026Entrapment of Device

  It was reported that the burr was stuck on the wire.A 1.75mm Rotapro and Rotawire Drive were selected for use. During the procedure, the wire and the burr got stuck. The burr was removed together with the wire. 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 50546938 ↗
• MalfunctionAug 20, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358885 ↗
• MalfunctionAug 18, 2026Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291913 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50130991 ↗
• InjuryJul 31, 2026Nonstandard Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  It was reported that the wire distal tip was separated.A 1.50mm Rotapro and a Rotawire Drive were selected for use in the severely calcified right coronary artery. During the procedure, it was noted that the wire was bent and the distal tip separated due to contact with the burr. The device fragment was entangled with a wire and removed. The procedure was completed with another of the same device. There were no patient complications, and the patient fully recovered after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50102938 ↗
• MalfunctionJul 29, 2026Entrapment of Device

  It was reported that the Rotopro burr and Rotawire Drive are completely locked.A 1.50mm Rotapro and Rotawire were selected for use. During preparation, it was noted that the Rotopro burr and Rotawire Drive are completely locked and cannot be removed from each other. The procedure was completed with another of the same device. There were no patient complications, and the patient condition was stable following procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075010 ↗
• DeathJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient died. It was reported that the patient presented with severe chest pain. A RotaLink Advancer, 1.25 mm RotaLink burr and RotaWire Drive were selected for treatment of the left circumflex (LCX) and left main (LM) arteries. Following rotablation, slow coronary flow was observed. Medications were administered to manage the patients condition. The patients blood pressure progressively declined and the patient experienced cardiac arrest. Direct current defibrillation and cardiopulmonary resuscitation were performed. Despite all efforts, there was no return of spontaneous circulation, no recordable pulse or blood pressure. The patient was declared dead. The official cause of death was slow flow and bradycardia.It was further reported that the patient also presented with shortness of breath, dyspnea and chest heaviness. Injections of adrenaline, atropine, calcium gluconate 10 ml and amiodarone 150 mg were administered during the procedure. Intra-Aortic Balloon Pump (IABP) and Temporary Pacemaker Implantation (TPI) support were also provided. Patient was shifted to the critical care unit and place on mechanical ventilation. The patient experienced ventricula

  Patient problems: Bradycardia; Cardiac Arrest; Diminished Pulse Pressure; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Tachycardia; Ventricular Fibrillation

  MAUDE report 50073731 ↗
• MalfunctionJul 21, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892822 ↗
• MalfunctionJul 8, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT BURR STUCK ON WIRE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING PROCEDURE, UPON FIRST ABLATION, THE SPEED DROPPED BY 3000 RPM. AFTER STARTING THE SECOND ABLATION, AN UNUSUAL NOISE OCCURRED AND THE SPEED DROPPED BY 20,000 RPM. THUS, THE ABLATION WAS DISCONTINUED. THE UNUSUAL NOISE PERSISTED WHEN ATTEMPTING TO REMOVE THE DEVICE WITH DYNAGLIDE. THEN, THE DEVICE GOT STUCK WITH THE WIRE. THE ROTABURR WAS REMOVED FROM THE BODY ALONG WITH THE ENTIRE ROTAWIRE. THE PHYSICIAN STATED THAT THE CLAMP FOR THE COCKTAIL SUPPLY MAY NOT HAVE BEEN COMPLETELY RELEASED. 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 25756495 ↗
• MalfunctionJul 2, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT BURR STUCK ON WIRE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE WAS SELECTED FOR USE. DURING USE, A DISCOMFORT WAS FELT, AND UPON REMOVAL, IT WAS NOTED THAT THE ROTABURR GOT STUCK WITH THE ROTAWIRE. THE ROTABURR WAS REMOVED TOGETHER WITH THE ROTOR WIRE. IT WAS OBSERVED THAT THE PROXIMAL PORTION OF THE WIRE WAS SLIGHTLY KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER AND WIRE. THERE WERE NO PATIENT COMPLICATIONS.

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

  MAUDE report 25694732 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROTAWIRE FRACTURED AND RETAINED INSIDE THE PATIENT. THE GREATER THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT AFTER THE REMOVAL OF ROTALINK PLUS 1.50MM, A PORTION OF THE RADIOPAQUE TIP ABOUT 0.014 INCHES OF THE ROTAWIRE DRIVE FLOPPY WAS FRACTURED IN THE DISTAL PART. THE PHYSICIAN CHOSE TO LEAVE THE FRAGMENT IN THE PATIENT, SINCE IT WAS IN A DISTAL BRANCH WITH NO RISK OF COMPLICATION. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 25452704 ↗
• InjuryMay 21, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE TIP WAS SEPARATED AND CAUSED PERFORATION. THE 18 MM SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH A VESSEL DIAMETER OF 3.00 MM. A 1.50 MM ROTAPRO AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. THE DEVICES WERE USED TO ABLATE THE LESION APPROXIMATELY 10 TIMES AT 180,000 RPM FOR 15-20 SECONDS EACH. DURING ABLATION, DUE TO CONTACT WITH THE BURR, THE PROXIMAL PORTION OF THE WIRE SEPARATED AND REMAINED IN THE BODY WHEN THE SYSTEM WAS REMOVED. A VESSEL WALL PERFORATION WAS NOTED AND A NON-SCIENTIFIC BALLOON WAS USED TO CONTROL THE BLEEDING. ATTEMPTS MADE TO RETRIEVE THE DETACHED WIRE WERE UNSUCCESSFUL AND THE FRAGMENT WAS SECURED WITH A STENT. PER THE ASSESSMENT OF THE PHYSICIAN, THE SEPARATION WAS CONSIDERED TO BE MORE RELATED TO THE CASE AND THE OPERATOR'S TECHNIQUE, RATHER THAN A PRODUCT DEFECT. THE PERFORATION WAS DUE TO A PROXIMAL VESSEL BEND OF LESS THAN 90 DEGREES. THE VESSEL ALSO MAINTAINED ITS SHAPE AND FAILED TO STRETCH DURING ROTABLATION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 25243951 ↗
• MalfunctionMay 20, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT A BURR STUCK WITH WIRE OCCURRED. A 1.50MM ROTAPRO AND ROTAWIRE WAS SELECTED FOR USE. DURING WITHDRAWAL, IT WAS NOTED THAT THE ROTA BURR GOT STUCK WITH THE ROTAWIRE. THE DEVICE WAS REMOVED FROM THE BODY ALONG WITH THE ENTIRE ROTAWIRE AND WAS RESOLVED OUTSIDE THE BODY BY CUTTING IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234728 ↗
• MalfunctionMay 15, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED ARTERY. A 1.50 MM ROTAPRO BURR AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTA BURR BECAME STUCK ON THE ROTAWIRE AND COULD NOT BE RELEASED. HOWEVER, THE ROTA BURR AND THE ROTAWIRE WERE SUCCESSFULLY REMOVED TOGETHER FROM THE BODY AS ONE UNIT. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186871 ↗
• InjuryMay 12, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A ROTAWIRE DRIVE WAS SELECTED FOR USE DURING A PERCUTANEOUS CORONARY INTERVENTION FOR THE TREATMENT OF THE CORONARY ARTERY DISEASE. DURING THE PROCEDURE, THE TIP OF A ROTAWIRE FLOPPY BROKE OFF INSIDE THE PATIENT. AFTER THE WIRE TIP BROKE OFF, THE DEVICE WAS REMOVED AND THE REMAINING WIRE TIP WAS STENTED TO KEEP IT IN PLACE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS DISCHARGED AND EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 25150231 ↗
• MalfunctionMay 1, 2026Entrapment of Device; Nonstandard 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 25058327 ↗
• MalfunctionApr 30, 2026Fracture

  IT WAS REPORTED VIA LITERATURE ARTICLE GUIDEWIRE FRACTURE OCCURRED. SLOW FLOW IS A FREQUENT COMPLICATION OF ROTATIONAL ATHERECTOMY (RA) FOR SEVERE CORONARY ARTERY CALCIFICATION (CAC), YET EFFECTIVE PREPROCEDURAL RISK STRATIFICATION TOOLS ARE LACKING. THE CHA2DS2 VASC HSF SCORE INCORPORATES MULTIPLE CARDIOVASCULAR RISK FACTORS AND MAY HELP PREDICT ADVERSE PROCEDURAL OUTCOMES. 256 PATIENTS WERE ANALYZED RETROSPECTIVELY WITH SEVERE CAC UNDERGOING RA. PATIENTS WERE DIVIDED INTO A SLOW FLOW GROUP (THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 0 TO 2) AND NORMAL FLOW GROUP (TIMI 3) BASED ON POST-RA ANGIOGRAPHIC ASSESSMENT. CLINICAL, PROCEDURAL, AND ANGIOGRAPHIC DATA WERE COMPARED. INDEPENDENT PREDICTORS WERE IDENTIFIED USING MULTIVARIATE LOGISTIC REGRESSION, AND RECEIVER OPERATING CHARACTERISTIC ANALYSIS ASSESSED THE PREDICTIVE PERFORMANCE OF VARIABLES. RA WAS PERFORMED USING THE ROTABLATOR SYSTEM (BOSTON SCIENTIFIC (BSC), USA), WHICH INCLUDES THE ROTAWIRE GUIDEWIRE, BURR, AND ADVANCER MECHANISM. INITIALLY, A STANDARD 0.014-INCH NON-BSC CORONARY GUIDEWIRE WAS ADVANCED ACROSS THE CALCIFIED LESION TO REACH THE DISTAL VESSEL SEGMENT. A NON-BSC MICROCATHETER WAS SUBSEQUENTLY USED TO FACILITAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048048 ↗

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-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