RotaLink™ Burr H802227680020Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 08714729185864), received between Dec 13, 2016 and Aug 21, 2026 — classified as 4 deaths, 17 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (52 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 111 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• DeathApr 30, 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 25048059 ↗
• MalfunctionApr 29, 2026Entrapment of Device

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT BURR WAS STUCK IN LESION. CURRENT GUIDELINES RECOMMEND ROTATIONAL ATHERECTOMY (RA) AS A RESCUE TREATMENT FOR CALCIFIED OR FIBROTIC LESIONS THAT CANNOT BE FULLY EXPANDED BEFORE STENT IMPLANTATION. PRESENT STUDY COMPARED THE PROCEDURAL AND ONE-YEAR CLINICAL OUTCOME OF PLANNED (PRA) OR RESCUE RA (RRA) FOR PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION WITH SEVERE CORONARY STENOSIS AND CALCIFICATION. A TOTAL OF 111 CONSECUTIVE PATIENTS WHO UNDERWENT RA AT (B)(6) HOSPITAL OF (B)(6) FROM (B)(6) 2021 TO (B)(6) 2023 WERE ENROLLED. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED THROUGH THE RADIAL ARTERY, BRACHIAL ARTERY OR FEMORAL ARTERY, AND UNFRACTIONATED HEPARIN 70 TO 100 U/KG WAS GIVEN BEFORE PCI. THE BOSTON SCIENTIFIC ROTABLATOR TM WAS USED FOR RA, AND THE RA HEAD WAS ROTA LINK TM (DIAMETERS: 1.25 MM, 1.50 MM, AND 1.75 MM, RESPECTIVELY). THE SIZE OF THE RA HEAD WAS SELECTED TO HAVE A RATIO OF 0.5 TO 0.6 BETWEEN THE RA HEAD DIAMETERS AND THE VESSEL DIAMETER, AND THE RA SPEED WAS 140,000 TO 160,000 RPM, AND EACH RA LASTED 10 TO 15 S. DURING RA, CONTINUOUS INTRACORONARY INFUSION OF A MIXTURE CONTAINING UNFRACTIONATED HEPARIN AND NITROG

  Patient problems: Foreign Body In Patient

  MAUDE report 25034504 ↗
• MalfunctionMar 10, 2026Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR CATHETER GOT STUCK WHEN CROSSING THE LESION AND COULD NOT BE SMOOTHLY CROSSED. THEREFORE, THE BURR WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED. AND ALSO CONFIRMED, THAT THE ISSUE REPORTED THAT THE BURR WAS NOT ACTUALLY STUCK WITHIN THE LESION, RATHER THE BURR CATHETER WAS DIFFICULT TO ADVANCE. THE DEVICE WAS REMOVED FROM THE PATIENT IN SIMPLY PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554641 ↗
• MalfunctionFeb 6, 2026Entrapment of Device; Output Problem

  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 24283312 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BURR GOT DETACHED FROM THE SHEATH. THE 10MM X 2.75MM IN DIAMETER, 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BURR GOT DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821622 ↗
• MalfunctionAug 18, 2025Nonstandard Device; Material Separation; Detachment of Device or Device Component; Nonstandard Device; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR CATHETER WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE BODY OF THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT IS STABLE AND IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834527 ↗
• MalfunctionAug 18, 2025Nonstandard Device; Material Separation; Detachment of Device or Device Component; Nonstandard Device; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE BODY OF THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT IS STABLE AND IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834524 ↗
• MalfunctionAug 18, 2025Entrapment of Device; Material Separation; Detachment of Device or Device Component; Output Problem; Entrapment of Device; Material Separation; Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT THE BURR CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR CATHETER GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS GOOD AND STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. DURING THE PROCEDURE, THE BURR ALSO STUCK FROM THE LESION. IT WAS THOUGHT THAT THE SPEED WAS LOWER THAN INTENDED AND STUCK WAS NOTICED. THE CATHETER WAS REMOVED NORMALLY AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834521 ↗
• MalfunctionAug 4, 2025Entrapment of Device; Difficult to Remove; Gas/Air Leak; Entrapment of Device; Difficult to Remove; Gas/Air Leak

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTALINK BURR AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTALINK BURR WAS STUCK WITH THE ROTAWIRE, THE ADVANCER WAS LEAKING GAS, AND THE PROCEDURE COULD NOT BE PERFORMED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE ROTALINK BURR AND ROTAWIRE WERE STUCK TOGETHER AND COULD NOT BE SEPARATED. THE DEVICES WERE DIFFICULT TO REMOVE, BUT THEY WERE EVENTUALLY REMOVED AS A WHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707453 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Nonstandard Device; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Output Problem; Intermittent Loss of Power; Entrapment of Device; Nonstandard Device; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USED. UPON DEVICE LOADING, A RESTRICTION WAS FELT IN THE BURR TIP AND THE CATHETER SHAFT. DURING THE PROCEDURE, THE SPEED WAS SET TO 180000 RPM. IT WAS NOTED THAT THE ADVANCER WAS LEAKING GAS; THE BURR STALLED, AND THE BURR TIP BECAME STUCK IN THE LESION. THE MAXIMUM SPEED REACHED WAS 160000 RPM. THE BURR CATHETER WAS REMOVED SEPARATELY FROM THE GUIDEWIRE, BY SWITCHING THE SPEED FROM HIGH TO LOW SPEED, AND MOVING THE BURR FORWARD AND BACKWARD, BEFORE EXITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311612 ↗
• MalfunctionJun 18, 2025Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 1.25MM ROTABLATOR AND ROTAWIRE WERE SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADVANCER LEAKED AIR, THE BURR WAS STALLED AND BECAME STUCK IN THE LESION. THE TARGET SPEED WAS 180,000 RPM AND THE ACTUAL SPEED WAS 160,000 RPM. THE BURR WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288627 ↗
• MalfunctionJun 3, 2025Entrapment of Device; Nonstandard Device; Mechanical Jam; Output Problem; Entrapment of Device; Nonstandard Device; Mechanical Jam; Output Problem

  IT WAS REPORTED THAT BURR GOT STUCK IN THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 1.25 MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCE IN A SET SPEED OF 160,000 RPM WITH A MAXIMUM SPEED REACHED UP TO 140,000 RPM. UPON ADVANCEMENT, A SIGNIFICANT RESISTANCE ENCOUNTERED BETWEEN THE BURR AND GUIDEWIRE, AND THE BURR WAS NOTED TO BE STUCK IN LESION. THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136599 ↗
• MalfunctionJun 2, 2025Entrapment of Device; Mechanical Jam; Output Problem; Entrapment of Device; Mechanical Jam; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING ADVANCEMENT USING A PECKING MOTION, THE BURR ENCOUNTERED SIGNIFICANT RESISTANCE AND SUBSEQUENTLY BECAME STUCK IN THE LESION. THE DECELERATION INDICATOR WAS ACTIVATED, AND THE MAXIMUM ROTATIONAL SPEED OBSERVED WAS 130,000 RPM DESPITE A SET SPEED OF 170,000 RPM. DYNAGLIDE MODE WAS USED DURING REMOVAL. THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT FROM THE PATIENT, AND THE GUIDEWIRE WAS ABLE TO BE SEPARATED FROM THE DEVICE WITH NO VISIBLE DAMAGE NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127533 ↗
• MalfunctionMay 12, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.25 MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT BY ATTEMPTING TO WITHDRAW THE ROTAWIRE AND ROTALINK BURR TOGETHER, WITHOUT ANY ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002787 ↗
• MalfunctionMay 7, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH WAS TORN AND LEAKED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE SEGMENT OF ANTERIOR DESCENDING BRANCH. A 1.25MM ROTALINK BURR WAS SELECTED FOR CORONARY ARTERY OCCLUSION PROCEDURE. DURING INTRODUCTION, THE BURR CATHETER ENTERED PATIENT AT A LOW ROTATION SPEED. IT WAS NOTED THAT THE OUTER SKIN OF THE SHEATH WAS TORN AND LEAKED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ROTALINK DEVICE. THERE WAS NO PATIENT COMPLICATION, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978891 ↗
• MalfunctionFeb 26, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. A 1.25MM ROTALINK BURR WAS SELECTED FOR ATHERECTOMY. THE ROTALINK BURR WAS UNABLE TO CONNECT TO THE ADVANCER HANDSHAKE CONNECTION. THE PROCEDURE WAS NOT COMPLETED, AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472315 ↗
• MalfunctionDec 10, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18NOV2024. IT WAS REPORTED THAT THE BURR GOT KINKED. THE 38MM X 2.5MM IN DIAMETER, 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR GOT KINKED AND IT COULD NOT BE DELIVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL DETACHED WITHIN THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892100 ↗
• MalfunctionNov 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BURR WAS LEAKING LIQUID. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE NARROW ANTERIOR DESCENDING BRANCH. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745310 ↗
• MalfunctionNov 20, 2024Leak/Splash; Noise, Audible; Leak/Splash; Noise, Audible

  IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. THE PATIENT PRESENTED WITH ISCHEMIC HEART DISEASE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING SPEED TEST, UPON CONNECTION, THE SYSTEM HAD ABNORMAL SOUND, IT WAS NOTED THAT THE DEVICE WAS LEAKING FLUID. THE DEVICE WAS REMOVED INTACT ALONG WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTAPRO DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737525 ↗

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-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• 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
• 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