RotaWire™ and wireClip™ Torquer H802228240020Recalls & reported problems

Summary

The FDA's MAUDE database contains 590 adverse event reports that list this exact device (DI 08714729185871), received between Nov 17, 2016 and Aug 4, 2026 — classified as 20 deaths, 177 injuries, 393 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (175 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 590 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131876 ↗
• MalfunctionAug 3, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50117316 ↗
• InjuryJul 29, 2026Difficult to Remove; Detachment of Device or Device Component

  It was reported that guidewire detachment and difficulty removal occurred, resulting in an unretrieved device fragment.The patient had diffused left anterior descending (LAD) lesions with severe calcification. A ROTAWIRE 330CM GW(5PK) FLOP was selected for use. During coronary intervention, the rotational atherectomy guidewire was advanced into the distal end of the vessel via a microcatheter. When the guidewire was withdrawn into the main vessel, angiography revealed that the guidewire had fractured approximately 1 cm within the branch. The fractured segment could not be removed due to the small vessel size. The patient experienced unspecified complications. The rotational atherectomy procedure was completed normally and the patient was stable.It was further reported that the target lesion was 80% stenosed. The device was not removed from the patient, and there are no plans for a repeat procedure. There were no patient complications.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 50070327 ↗
• MalfunctionJul 21, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894150 ↗
• MalfunctionJul 21, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894087 ↗
• MalfunctionJun 24, 2026Contamination; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A ROTAWIRE WAS SELECTED FOR USE. DURING PREPARATION, THE ROTAWIRE GOT UNSTERILE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25615409 ↗
• MalfunctionJun 23, 2026Fracture; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE. A 330CM ROTAWIRE-IC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BROKE UPON ENTERING THE WARHEAD, MAKING IT IMPOSSIBLE TO MOVE FORWARD. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600535 ↗
• MalfunctionJun 23, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT ROTALINK BURR GOT STUCK WITH THE ROTAWIRE. A 1.25 MM ROTABLATOR ROTALINK PLUS BURR AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BURR WAS JAMMED AND COULD NOT BE ADVANCED. WHEN ATTEMPTING TO REMOVE THE ROTAWIRE, IT BECAME STUCK WITH THE BURR. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595762 ↗
• MalfunctionJun 15, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE GUIDEWIRE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE WAS CROSSED THROUGH THE LESION AND ROTAPRO 1.50MM BURR WAS LOADED OVER THE ROTAWIRE. WHILE TESTING THE SPEED OF THE DEVICE, THE BURR STOPPED ROTATING AND IT WAS NOTED THAT THE BURR WAS STUCK ON THE WIRE. THE ROTAWIRE WAS REMOVED FROM THE BODY, AND THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL ROTAWIRE AND BURR. THERE WERE NO COMPLICATIONS AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513158 ↗
• MalfunctionJun 3, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT GUIDEWIRE WAS KINKED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379737 ↗
• MalfunctionMay 27, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2026 (B)(6). IT WAS REPORTED THAT THE ROTAWIRE GOT KINKED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTAWIRE 330CM GW(5PK) FLOP WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE GOT KINKED WHILE LOADING THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS SHOWED THAT A PORTION OF THE GUIDEWIRE WAS NOTED TO BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305895 ↗
• MalfunctionMay 21, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A 330CM GW(5PK) FLOP ROTAWIRE-IC WAS SELECTED FOR USE. DURING PREPARATION, THE TIP WAS OF THE ROTAWIRE WAS BIFURCATED. 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 25244000 ↗
• InjuryMay 13, 2026Fracture; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A WIRE FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, A FLOPPY WIRE WAS EXCHANGED FOR A ROTAWIRE. WHEN THE ROTAWIRE REACHED THE DISTAL, FLUOROSCOPY REVEALED THE DISTAL SEGMENT OF THE WIRE HAD FRACTURED. THE DEVICE WAS REMOVED USING A NON-BOSTON SCIENTIFIC MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT REMAINED STABLE WITHOUT ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158641 ↗
• MalfunctionMay 5, 2026Fracture; Nonstandard Device

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A ROTAWIRE-IC WAS SELECTED FOR USE AND POSITIONED IN THE TARGET ARTERY FOR TREATMENT WITH THE ROTABLATOR SYSTEM. DURING THE DRAW TEST, AS THE GUIDEWIRE WAS ADVANCED THROUGH THE DEVICE CATHETER SPECIFICALLY IN THE REGION NEAR THE INTRODUCER, IT WAS NOTED THAT THE GUIDEWIRE FRACTURED. AS A RESULT, ONE PORTION OF THE GUIDEWIRE REMAINED INSIDE THE PATIENT, WHILE THE OTHER PORTION REMAINED OUTSIDE, WITHIN THE ROTABLATOR CATHETER. THE GUIDEWIRE WAS IMMEDIATELY REPLACED WITH ANOTHER OF THE SAME DEVICE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084078 ↗
• MalfunctionApr 17, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25MAR2026. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 330CM ROTAWIRE WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE WIRE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS EXPECTED TO FULLY RECOVER. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PORTION OF THE DISTAL END WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913637 ↗
• MalfunctionApr 6, 2026Nonstandard Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2026. IT WAS REPORTED THAT THE WIRE TIP WAS STRETCHED. THE 23MM X 3.0MM IN DIAMETER, 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING UNPACKING OF THE ROTAWIRE, IT WAS FOUND THAT THE TIP OF THE GUIDE WIRE WAS STRETCHED AND COULD NOT BE OPERATED. AFTER 3 TO 4 ATTEMPTS, IT STILL COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME WIRE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790975 ↗
• DeathMar 2, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 1.25MM ROTABLATOR PLUS AND 330CM ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHILE DOING ROTATIONAL ATHERECTOMY ANGIOPLASTY, THE BURR STUCK AND INDUCED A PERFORATION, WHICH CAUSED THE PATIENT TO EXPIRE.

  Patient problems: Perforation

  MAUDE report 24484772 ↗
• MalfunctionFeb 6, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE GUIDEWIRE AND BURR WERE STUCK TOGETHER. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 330CM ROTAWIRE AND 1.25MM ROTALINK BURR WERE USED FOR ROTATIONAL ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDE WIRE AND BURR WERE STUCK TOGETHER AND THE ROTATION SPEED ONLY REACHED 153000 RPM FROM ITS SET SPEED OF 160000 RPM. THE BURR AND WIRE WERE NORMALLY REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279785 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED. THE 80% STENOSED TARGET LESION WAS LOCATED AT THE PROXIMAL SEGMENT OF LEFT ANTERIOR DESCENDING BRANCH. A 330CM ROTAWIRE WAS SELECTED FOR USE. DURING PREPARATION, AFTER THE GUIDEWIRE WAS UNPACKED, IT WAS NOTED THAT THE COIL AT THE TIP WAS DETACHED. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269685 ↗
• MalfunctionDec 30, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTAPRO BURR AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDE WIRE WOUND AROUND THE BURR, AND IT COULD NOT BE USED NORMALLY. THE DEVICES WERE REMOVED AND PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924464 ↗
• MalfunctionDec 19, 2025Fracture; Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material; Fracture; Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A ROTAWIRE WAS SELECTED FOR USE. UPON UNPACKING, THE ROTAWIRE WAS FLUSHED WITH 3 X 10ML SYRINGES THROUGH THE BLUE TUBE OF THE CAROUSEL. WHEN TRYING TO REMOVE THE GUIDE WIRE FROM THE CAROUSEL, RESISTANCE WAS NOTED. THE CAROUSEL WAS TAPPED A FEW TIMES TO ACTIVATE THE LUBRICATING POWDER ON THE GUIDE WIRE BUT WAS NOT SUCCESSFUL. WHEN FORCING THE ITEM TO BE REMOVED FROM THE CAROUSEL, THE GUIDE WIRE ENDED UP CRACKING. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850145 ↗
• DeathDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE FRAGMENT RETENTION OCCURRED. A 330CM ROTAWIRE WAS SELECTED FOR USE. DURING ELECTIVE ANGIOPLASTY WITH A ROTABLATOR, THERE WAS INTRAVASCULAR RETENTION OF A GUIDE FRAGMENT. AN ATTEMPT TO REMOVE IT WAS MADE, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS REFERRED TO THE ICU FOR CONTINUED CARE. IT WAS FURTHER REPORTED THAT COMPLICATIONS AROSE AND THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23769371 ↗
• MalfunctionNov 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24OCT2025. IT WAS REPORTED THAT THE TIP WAS KINKED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTAWIRE WAS SELECTED FOR USE. DURING UNPACKAGING, THE TIP WAS KINKED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23588370 ↗
• MalfunctionNov 17, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20OCT2025 IT WAS REPORTED THAT DEVICE COULD NOT CROSS THE LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING. A ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT A DETACHED PORTION OF THE SPRING TIP WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569204 ↗
• InjuryNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A ROTOWIRE WAS SELECTED FOR ROTABLATION. DURING WITHDRAWAL, IT WAS NOTED THAT A PIECE OF THE GUIDEWIRE APPROXIMATELY 1 CM WAS MISSING FROM THE TIP, WHICH REMAINED IN A VERY DISTAL POSITION INSIDE THE PATIENT. DUE TO ITS DISTAL LOCATION, THE DETACHED TIP COULD NOT BE RETRIEVED USING A SNARE. THE DEVICE WAS NOTE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION WITHOUT ANY COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23550128 ↗

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