RotaLink BurrRecalls & reported problems across all models

We found 6 models of RotaLink Burr by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 313 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Sep 16, 2026 — classified as 8 deaths, 42 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (134 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 RotaLink Burr problems

RotaLink Burr models

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

• RotaLink™ Burr H802227680030

  CATHETER, CORONARY, ATHERECTOMY
  3 deaths149 reports
• RotaLink™ Burr H802227680020

  CATHETER, CORONARY, ATHERECTOMY
  4 deaths111 reports
• RotaLink™ Burr H802227680040

  CATHETER, CORONARY, ATHERECTOMY
  1 death38 reports
• RotaLink™ Burr H802227680050

  CATHETER, CORONARY, ATHERECTOMY
  11 reports
• RotaLink™ Burr H802227680150

  CATHETER, CORONARY, ATHERECTOMY
  3 reports
• RotaLink™ Burr H802227680060

  CATHETER, CORONARY, ATHERECTOMY
  1 report

Recent RotaLink Burr adverse event reports

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

• MalfunctionSep 16, 2026Material Split, Cut or Torn; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791657 ↗
• MalfunctionSep 15, 2026Material Separation

  It was reported that the burr was fractured.The 98% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. A 1.50mm RotaLink Burr was selected for use. During the procedure, it was noted that the burr of the device was fractured. The device was removed and the procedure was completed with another of the same device. There were no patient complications, and the patient was stable after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773280 ↗
• MalfunctionSep 10, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718908 ↗
• MalfunctionSep 4, 2026Material Separation; Difficult to Advance; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600200 ↗
• MalfunctionAug 21, 2026Decoupling; Material Separation

  It was reported that the burr detached. The target lesion was anterior descending branch. A 1.25mm RotaLink Burr was advanced for treatment. During the procedure, it was noted that burr fell off and the device could not be used normally. The procedure was completed with a different device. 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 50376448 ↗
• MalfunctionAug 6, 2026Material Separation; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158621 ↗
• 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) andTemporary Pacemaker Implantation (TPI) support was also provided. Patient was shifted to the critical care unit and place on mechanical ventilation. The patient experienced ventricular

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

  MAUDE report 50074065 ↗
• MalfunctionJul 22, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905851 ↗
• MalfunctionJul 21, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894153 ↗
• MalfunctionJul 13, 2026Nonstandard Device; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT STALL WAS SHOWN DURING TESTING OUTSIDE THE PATIENT. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, THE BURR WAS CONNECTED SUCCESSFULLY. STALL WAS SHOWN DURING TESTING OUTSIDE THE PATIENT, BUT IT STILL COULD NOT BE SOLVED AFTER ADJUSTING THE SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25801001 ↗
• MalfunctionMay 15, 2026Nonstandard Device; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT A GUIDEWIRE RESTRICTION OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.25MM ROALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, PRIOR TO REACHING THE LESION LOCATION, THE BURR WAS DIFFICULT TO ADVANCE ON THE ROTAWIRE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. HOWEVER, DEVICE ANALYSIS REVEALED THE SHEATH WAS BENT (TWISTED), WORN AND TORN 3 CM TO 3.3CM DISTAL FROM THE STRAIN RELIEF, AND AT 6CM TO 6.3CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186878 ↗
• MalfunctionMay 12, 2026Decoupling; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.50 MM ROTALINK BURR AND ROTALINK ADVANCER W/ TUBULAR DRIVE SHAFT WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER INSERTING INTO THE BODY, THE BURR COULD NOT MOVE IN AND OUT ALONG WITH THE ADVANCER. WHEN PULLED OUT OF THE BODY, IT WAS FOUND THAT THE CONNECTION BETWEEN THE ADVANCER AND THE BURR WAS DISCONNECTED. THE DEVICE MALFUNCTIONED AND THE PROCEDURE WAS CANCELLED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150149 ↗
• DeathMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ARTICLE PATIENT DEATH 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. SLOW FLOW OCCURRED IN 18.8% OF PATIENTS. THE SLOW FLOW GROUP HAD SIGNIFICANTLY HIGHER CHA2DS2 VASC HSF SCORES, LONGER LESION LENGTHS, SMALLER REFERENCE VESSEL DIAMETERS, AND LOWER PREPROCEDURAL SYSTOLIC BLOOD PRESSURE (SBP). MULTIVARIATE ANALYSIS IDENTIFIED ALL FOUR AS INDEPENDENT PREDICTORS. THE CHA2DS2 VASC HSF SCORE ALONE HAD MODERATE PREDIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057739 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT BURR WAS STUCK IN LESION. 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 FACILIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049912 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT BURR WAS STUCK IN LESION. 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 FACILIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048061 ↗

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