Peripheral RotaWire and wireClip TorquerRecalls & reported problems across all models

We found 2 models of Peripheral RotaWire and wireClip Torquer by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between May 30, 2017 and Jun 18, 2026 — classified as 1 death, 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Peripheral RotaWire and wireClip Torquer problems

Peripheral RotaWire and wireClip Torquer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Peripheral RotaWire™ and wireClip® Torquer M0011373320

  Catheter, peripheral, atherectomy
  1 death29 reports
• Peripheral RotaWire™ and wireClip® Torquer M0011373310

  Catheter, peripheral, atherectomy
  1 report

Recent Peripheral RotaWire and wireClip Torquer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Contamination; Positioning Problem

  IT WAS REPORTED THAT GUIDEWIRE POSITION LOSS OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED BELOW THE KNEE ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. WHEN THE ROTA BURR WAS REMOVED FROM THE BODY THE WIRE CAME OUT AS WELL. THE WIRE TOUCHED A NON-STERILE ITEM. 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 25550633 ↗
• InjuryOct 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BURR WAS DISLODGED AND STUCK IN THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ARTERY ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE AND THE DEVICE WERE LODGED IN A CHRONIC OCCLUSION IN THE PERONEAL ARTERY. THE DEVICES COULD NOT BE WITHDRAWN THROUGH THE COMMON FEMORAL ARTERIOTOMY. INTERVENTION INCLUDED EXPOSING THE PERONEAL ARTERY THROUGH THE LOWER LEG TO CUT THE DEVICE FREE AT THE DISTAL END OF THE DEVICE. THE REST OF THE ROTABLATOR WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE LESION WAS 4-5MM LONG. THE PATIENT WAS MEDICATED WITH VERAPIMIL AND NITRO IN THE ROTAGLIDE SOLUTION. THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310510 ↗
• MalfunctionOct 7, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE WAS DELIVERED THROUGH THE RUBICON CATHETER. THERE WAS A RESISTANCE EXCHANGING THE WIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234500 ↗
• MalfunctionOct 3, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A BURR AND WIRE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO DISTAL ANTERIOR TIBIAL ARTERY (ATA). A 1.25 MM ROTAPRO-PI AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE IN ACCORDANCE WITH STANDARD ATHERECTOMY INDICATIONS. BURR ADVANCEMENT WAS PERFORMED USING A PECKING MOTION APPROXIMATELY 75% OF THE TIME. THE BURR WAS USED CLOSE TO THE ORIGIN OF THE ATA AND TRAVELED DISTALLY TOWARD THE PEDAL ARTERIES. MIDWAY THROUGH THE ATA, THE BURR BEGAN TO STALL, INCLUDING DURING DYNAGLIDE MODE. ADVANCEMENT BECAME DIFFICULT AT THE MIDPOINT OF THE LESION. IT WAS OBSERVED THAT THE GUIDEWIRE WAS NOT FREELY MOVING WITHIN THE VESSEL AND WAS MOVING TOGETHER WITH THE BURR, INDICATING THE BURR HAD BECOME STUCK ON THE WIRE. MULTIPLE ATTEMPTS WERE MADE TO DISLODGE THE BURR USING BOTH NORMAL AND DYNAGLIDE MODES, BUT THESE WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO REMOVE THE ROTAPRO BURR; HOWEVER, IT COULD NOT BE EXTRACTED INDEPENDENTLY OF THE WIRE. CONSEQUENTLY, BOTH THE BURR AND GUIDEWIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. POST-REMOVAL, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214042 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF AND WAS LEFT INSIDE THE PATIENT. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A PERIPHERAL ROTAWIRE GUIDEWIRE AND A PERIPHERAL ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE SPEED WAS SET TO 160 RPM; HOWEVER, THE SPEED REACHED UP TO 163 RPM. UPON EXCHANGING ROTAWIRE TO ANOTHER GUIDEWIRE, IT WAS NOTED THAT THE 5MM TIP OF THE ROTAWIRE BROKE OFF AND REMAINED DISTAL LAD VERY CLOSE TO THE APEX. THE PHYSICIAN BELIEVE THAT THE TIP OF THE WIRE WAS PULLED TOO HARD WHILE BEING TAKEN OUT OF THE WIRE HOOP. THE PROCEDURE PROCEEDED AS PLANNED AND COMPLETED USING ORIGINAL METHOD. THE FRAGMENT WAS NOT REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22778236 ↗
• InjuryJun 6, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE BROKE OFF AND WAS UNRETRIEVED. THE PATIENT WAS NOT DISCHARGED FROM THE HOSPITAL. THE 89% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SEGMENT FROM THE POPLITEAL ARTERY TO THE PROXIMAL ANTERIOR TIBIAL ARTERY. A PER ROTA WIRE EXSUP WAS SELECTED FOR LEFT LEG ATHERECTOMY. DURING THE PROCEDURE, THE WIRE WAS CHECKED IF IT IS STILL IN PLACE AND A SMALL PIECE OF THE END OF THE WIRE WAS NOTICED TO BE SEPARATED FROM THE WIRE ITSELF. A SPIDER FILTER WAS PLACED BEYOND THE PIECE OF THE WIRE IN THE HOPES OF CAPTURING IT AFTER A FEW TRIES WITHOUT SUCCESS AND A SMALL SEGMENT OF THE TIP AT 5MM IN LENGTH REMAINS AND WILL REMAIN IN THE PATIENT'S DISTAL AT/PEDAL ARTERY. AN OVER THE WIRE (OTW) STERLING BALLOON WAS INFLATED IN THE AT ARTERY (ABOVE THE WIRE PIECE) AS WOULD NORMALLY BE DONE AFTER ATHERECTOMY. NO FLOW WAS OBSERVED FOR A SHORT SEGMENT FROM DISTAL POPLITEAL TO PROXIMAL AT ARTERY. ADDITIONALLY, IT WAS NOTICED THAT THE DISTAL POPLITEAL AS WELL AS THE PROXIMAL AT ARTERY WAS THROMBOSED. PATIENT WAS TRANSFERRED TO THE HOSPITAL TO HAVE A CATHETER PLACED FOR THROMBOLYSIS ACROSS AREA THAT WAS THROMBOSED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22159740 ↗
• InjuryMar 6, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE WIRE DETACHED, AND ADDITIONAL SURGERY WAS REQUIRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A ROTAWIRE WAS SELECTED FOR ATHERECTOMY. DURING PROCEDURE, FOLLOWING ROTABLATION, A STERLING BALLOON WOULD NOT ADVANCE OVER THE WIRE AND THE WIRE APPEARED KINKED. THE WIRE THEN BROKE INTO TWO PIECES, MID WIRE. FURTHERMORE, THE PATIENT UNDERWENT ENDARTERECTOMY AND THE DISTAL END OF THE ROTAWIRE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848565 ↗
• MalfunctionJan 23, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A DEVICE ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED POSTERIOR TIBIAL ARTERY. A 1.75MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN ADVANCING THE BURR THROUGH THE LESION, THE BURR WAS NOT SPINNING, AND THE WIRE WAS FLOPPING ON THE BACK TABLE INDICATING THAT THE BURR WAS STUCK ON THE WIRE. THE BURR AND WIRE WERE REMOVED TOGETHER AS ONE UNIT. THERE SEEMED TO BE AN INTIMAL TISSUE WRAPPED AROUND THE CATHETER TIP WHEN REMOVED, THAT WAS SUSPECTED TO BE THE CAUSE OF THE DEVICE BECAME STALL AND STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566175 ↗
• MalfunctionJul 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR ATHERECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS A WHITE SMUDGE ON THE DISTAL END OF THE ROTAWIRE. THE DEVICE WAS NOT USED, AND 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 17270738 ↗
• InjuryMar 8, 2023Fracture; Detachment of Device or Device Component; Material Deformation; Fracture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE WAS FRACTURED AND AN ADDITIONAL SURGERY WAS REQUIRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY (PT). A PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER - BX5 WAS SELECTED FOR USE AND INSERTED THROUGH A BERN CATHETER. DURING THE PROCEDURE, THE 5FR BERN CATHETER WAS REMOVED AND LEFT-SIDED 5/6 FR SLENDER SHEATH ACCESS WAS LOST. UPON REINSERTION OF THE PEDAL SHEATH OVER THE WIRE, THE ROTAWIRE LOOPED, KINKED AND BROKE OFF IN THE FOOT. NO HEMATOMA OR ACTIVE BLEEDING WAS NOTED. THE PHYSICIAN ATTEMPTED TO RE-STICK THE LEFT PT WITH THE ULTRASOUND GUIDANCE, BUT NO VESSEL WAS VISUALIZED AND SPASM WAS PRESUMED. RIGHT COMMON FEMORAL ARTERY ACCESS WAS OBTAINED WITH A 6FR SHEATH. HOWEVER, THE PHYSICIAN NOTICED THAT THE ROTAWIRE WAS NOW LOCATED IN THE DESCENDING SUPERIOR VENA CAVA. A 6FR SNARE WAS USED IN AN ATTEMPT TO REMOVE THE DEVICE. THE ROTAWIRE WAS PULLED INTO THE RIGHT COMMON ILIAC ARTERY, BUT BROKE IN THE SNARE. THE INTENDED PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS THEN TRANSPORTED TO A VASCULAR SURGEON FOR REMOVAL OF THE WIRE. A SMALL INCISION WAS MADE IN THE TOP OF THE LEFT FOOT AND

  Patient problems: Vasoconstriction

  MAUDE report 16503731 ↗
• InjuryJul 28, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS BLOOD-TINGED TISSUE PRESENT ON THE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A 2.00MM PERIPHERAL ROTALINK PLUS SYSTEM BEGAN MAKING A HIGH-PITCHED NOISE AND THE BURR SEEMED TO BE STUCK AS THE PHYSICIAN ATTEMPTED TO MOVE IT SLIGHTLY BACK AND FORTH WITHOUT SUCCESS. THE PHYSICIAN THEN SWITCHED TO DYNAGLIDE MODE TO COMPLETELY REMOVE THE BURR OUT OF THE PATIENT'S BODY AND WAS ABLE TO DO SO. WHEN THE ROTAWIRE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THERE WAS BLOOD-TINGED TISSUE PRESENT ON THE WIRE. 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 15121456 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE ROTAWIRE WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A ROTAWIRE AND WIRECLIP TORQUER (BX5) AND A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE FOOT PEDAL WAS STEPPED ON AND BEGAN TO ADVANCE THE BURR, IT WAS MAKING AN ABNORMAL SOUND. THE DEVICE WAS STOP AND PULLED BACK THE ROTAWIRE A BIT BUT THE END OF THE WIRE WAS NOT COMING BACK. THE PHYSICIAN ASSUMED THE WIRE WAS BROKEN APPROXIMATELY 20-30 CM FROM DISTAL END. THEY REMOVED THE PROXIMAL PORTION OF THE ROTAWIRE WHILE THE DISTAL PORTION REMAIN VISIBLE BEYOND THE ROTA DEVICE IN THE TIBIAL. WHEN THE ROTALINK PLUS WAS REMOVED, THE DISTAL WIRE CAME WITH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066527 ↗
• MalfunctionFeb 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED PERINEAL ARTERY. A 2.5MMX150MMX150CM COYOTE AND A 330CM ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT NOMINAL PRESSURE AND IT WAS NOTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. BOTH BALLOON AND ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534780 ↗
• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE BECAME SEPARATED. THE 50-70% TARGET LESION WAS LOCATED IN THE MILDLY - NON TORUTOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE .014 PORTION OF THE WIRE BECAME SEPARATED FROM .009 PORTION. THE WIRE AND TIP WERE REMOVED INTACT THROUGH RUBICON CATHETER AND NO PORTION OF THE WIRE EMBOLIZED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745438 ↗
• InjuryAug 24, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE ROTAWIRE BROKE AND WAS SNARED TO REMOVE. VASCULAR ACCESS WAS OBTAINED VIA ANTERIOR TIBIAL (AT) ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE WAS USED FOR SUCCESSFUL ATHERECTOMY OF THE AT ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA), AND WAS THEN USED AS A RAIL TO BALLOON THE AT ARTERY. WHEN REMOVING THE BALLOON, THE NON-BSC SHEATH CAME OUT OF THE ACCESS POINT OUT OF THE BODY. WHEN TRYING TO REINSERT THE SHEATH OVER THE ROTAWIRE, THE SHEATH WAS UNABLE TO ADVANCE. THE ROTAWIRE WAS MANIPULATED SEVERAL TIMES. IT WAS PULLED BACK, LOOPED, AND KINKED ON ITSELF. THE ROTAWIRE BROKE IN HALF INSIDE THE PATIENT BODY. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY (CFA). A SNARE WAS SUCCESSFULLY USED TO REMOVE THE REMAINING ROTAWIRE INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359616 ↗

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