RotaWire and wireClip TorquerRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 718
- Deaths reported
- 22
- Injuries reported
- 207
- Recalls
- 0
We found 2 models of RotaWire and wireClip Torquer by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 718 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Aug 6, 2026 — classified as 22 deaths, 207 injuries, 489 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (229 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
Reports received per month, all models
Most reported RotaWire and wireClip Torquer problems
Device problems
- Entrapment of Device229
- Fracture175
- Detachment of Device or Device Component114
- Material Deformation75
- Adverse Event Without Identified Device or Use Problem61
- Difficult to Remove41
- Device Contamination with Chemical or Other Material36
- Detachment Of Device Component26
Patient problems
- No Consequences Or Impact To Patient307
- No Clinical Signs, Symptoms or Conditions193
- Device Embedded In Tissue or Plaque98
- Foreign Body In Patient50
- No Patient Involvement25
- Perforation of Vessels20
- Death11
- No Known Impact Or Consequence To Patient11
RotaWire and wireClip Torquer models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RotaWire™ and wireClip™ Torquer H802228240020CATHETER, CORONARY, ATHERECTOMY20 deaths590 reports
- RotaWire™ and wireClip™ Torquer H802232390010CATHETER, CORONARY, ATHERECTOMY2 deaths128 reports
Recent 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.
MalfunctionAug 6, 2026Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159484 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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