RotaLink™ Burr H802227680040Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729185840), received between Oct 26, 2017 and Apr 30, 2026 — classified as 1 death, 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (18 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 38 reports, in the reporter's own words as published by the FDA.

• 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 25048044 ↗
• 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 PREDICTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048038 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. 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 THE FOURTH HOSPITAL OF WUHAN FROM JULY 2021 TO JUNE 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 N

  Patient problems: Angina; Arrhythmia; Bradycardia; Heart Failure/Congestive Heart Failure; Myocardial Infarction; Obstruction/Occlusion; Reduced Blood Flow; Unspecified Heart Problem; Vascular Dissection; Vasoconstriction; Vasospasm

  MAUDE report 25035185 ↗
• 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 25034528 ↗
• MalfunctionMar 5, 2026Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. A 1.75MM ROTABLATOR ROTALINK BURR AND ROTAWIRE - IC WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OLIVE GOT STUCK ON THE CORD AND WAS UNABLE TO ROTATE. 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 24519583 ↗
• MalfunctionMar 2, 2026Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE GRINDING HEAD WAS BROKEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487166 ↗
• MalfunctionSep 8, 2025Nonstandard Device; Material Separation; Detachment of Device or Device Component; Nonstandard Device; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING ARTERY. A1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS. THE DETACHED BURR TIP WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994629 ↗
• InjuryJul 31, 2025Entrapment of Device; Difficult to Remove; Intermittent Loss of Power; Entrapment of Device; Difficult to Remove; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION, DISSECTION OCCURRED, AND SURGERY WAS REQUIRED. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS CORONARY ROTATIONAL ATHERECTOMY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR STALLED WHEN CROSSING A CALCIFIED AREA IN THE MIDDLE SEGMENT OF THE LAD. UPON RETRACTION, THE BURR BECAME STUCK AT THE LESION AND COULD NOT BE STARTED AND REMOVED. ANGIOGRAPHY SHOWED THAT FORWARD BLOOD FLOW IN THE LAD WAS TIMI GRADE 3 WITH NO CHEST PAIN SYMPTOMS. THE CATHETER OF THE BURR WAS CUT IN A FAILED ATTEMPT TO REMOVE THE BURR WITH THE SUPPORT OF A GUIDEZILLA DEVICE. RIGHT FEMORAL ARTERY ACCESS WAS OBTAINED, AND A 6F ARTERIAL SHEATH WAS INSERTED. A NON-BOSTON SCIENTIFIC GUIDING CATHETER WAS THEN DELIVERED TO THE OPENING OF THE LEFT CORONARY ARTERY (LCA). HOWEVER, IT WAS DIFFICULT TO CROSS THE LESION SITE WITH TWO DIFFERENT NON-BOSTON SCIENTIFIC GUIDEWIRES. A 1.2MM X 8MM AND A 1.5MM X 15MM NON-BOSTON SCIENTIFIC BALLOONS WERE THEN USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677414 ↗
• MalfunctionJul 11, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE LESION. THE 18MM X 3.5 IN DIAMETER, 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT STUCK IN THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE ENTIRE SYSTEM. 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 22487699 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION, SLOW BLOOD FLOW AND ARRYTHMIA OCCURRED AND THE PATIENT EXPIRED. THE PATIENT WAS ELDERLY, WITH TRIPLE-VESSEL CORONARY ARTERY DISEASE AND WAS CONSIDERED HIGH-RISK WITH COMPLEX LESIONS. CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY WAS RECOMMENDED HALF A MONTH PRIOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6)2025 REQUESTING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE DOCTOR, PHYSICIAN, AND THE HOSPITAL MEDICAL AFFAIRS DEPARTMENT HAD THOROUGH COMMUNICATION AND INFORMED THE FAMILY OF THE HIGH RISKS INVOLVED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. ANGIOGRAPHY AND OPTICROSS INTRAVASCULAR ULTRASOUND (IVUS) BOTH REVEALED 99% STENOSIS, SEVERELY CALCIFIED LESIONS IN THE MID-PROXIMAL SEGMENT IN THE RIGHT CORONARY ARTERY (RCA). ADDITIONALLY, DIFFUSE CALCIFIED LESIONS WITH 80-90% STENOSIS WERE OBSERVED IN THE MID-PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIFFUSE CALCIFIED LESIONS WITH 99% STENOSIS IN THE DIAGONAL BRANCH. DIFFUSE CALCIFIED LESIONS WITH 80-90% STENOSIS WERE ALSO NOTED IN THE MID-PROXIMAL SEGMENT OF THE LEFT CIRCUMFLEX ARTERY (LCX). A 2.0 X 20MM MAVERICK BALLOON WAS INFLATED AT 12 ATMOSPHERES (ATM) TO DIL

  Patient problems: Atrial Fibrillation; Chest Pain; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Vascular Dissection; Ventricular Fibrillation

  MAUDE report 21939691 ↗
• MalfunctionJan 24, 2025Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. A 1.75MM ROTALINK BURR AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHILE ADVANCING THE BURR, THE BURR WAS STUCK WITH THE WIRE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233131 ↗
• MalfunctionDec 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS STUCK. THE 85% STENOSED, 31MM X 3.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE BURR TIP WAS STUCK AND THE DEVICE WAS COMPLETELY REMOVED TOGETHER WITH THE WHOLE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988559 ↗
• MalfunctionJun 13, 2024Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR WAS STUCK IN LESION. THE 85% STENOSED, 60 MM X 3.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTALINK BURR WAS SELECTED FOR CORONARY INTERVENTIONAL PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SPEED WAS NOT ENOUGH, AND THE BURR WAS STUCK IN THE LESION. THE PROCEDURE SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET AND OBSERVED MAXIMUM ROTATIONAL SPEED WAS 180,000 RPM. THE ROTALINK BURR AND THE ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533320 ↗
• MalfunctionMay 24, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. A 95% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIRO DESCENDING ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. THE ROTATION SPEED WAS SET CORRECTLY TO 50000 RPM TO 120000 RPM. HOWEVER, DURING PROCEDURE, THE MAXIMUM SPEED REACHED WAS 190000 RPM. 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 19393612 ↗
• MalfunctionNov 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A CONNECTION ISSUE AND BREAK OCCURRED, AND THE PROCEDURE WAS CANCELLED. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE HANDSHAKE CONNECTION OF THE BURR WAS BENT AND POSSIBLY BROKEN. IT WAS NOT POSSIBLE TO CONNECT THE BURR TO THE ADVANCER. THE PROCEDURE WAS NOT CONTINUED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED AND CONFIRMED THAT PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230362 ↗
• MalfunctionSep 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BURR FRACTURED. THE TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED CORONARY ARTERY. A 1.75MM ROTABLATOR WAS SELECTED FOR ROTATIONAL ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS FRACTURED, BUT NOT COMPLETELY BROKEN INTO TWO PIECES, SO THEY JUST PULLED IT OUT DIRECTLY. THE DEVICE WAS COMPLETELY REMOVED FROM THE BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691972 ↗
• MalfunctionJun 13, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 15MMX3.0MM, STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTALINK BURR AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTAWIRE WAS INTERTWINED WITH THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119434 ↗
• MalfunctionNov 23, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE 80% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 330CM ROTAWIRE AND A 1.75MM ROTALINK BURR WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. THE DEVICES COULD NOT BE SEPARATED AND WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851976 ↗
• MalfunctionSep 8, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26AUG2022. IT WAS REPORTED THAT THE HANDSHAKE CONNECTION WAS KINKED AND BURR COULD NOT CROSS. THE 94% STENOSED, 10MMX2.75MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE HANDSHAKE CONNECTION WAS KINKED AND BURR COULD NOT CROSS THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH AND COIL WERE FOUND TO BE CUT AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380947 ↗
• InjuryDec 7, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT BURR BECAME STUCK AND PERFORATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MIDDLE RIGHT CORONARY ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK ON THIRD RUN DECELERATION. DYNAGLIDE MODE WAS USED AND TRIED TO PULL THE BURR, HOWEVER, IT WAS UNABLE TO GET AN ADDITIONAL NON BSC WIRE PROXIMAL TO STUCK BURR WITH INTENT TO THE BALLOON. NORMAL MODE WAS USED AND THE BURR WAS ABLE TO RETRIEVED. SUBSEQUENTLY, A PERFORATION OCCURRED IN THE PROXIMAL RIGHT CORONARY ARTERY. MICROCATHETER WAS USED TO DELIVER WIRE, BALLOON AND STENTS WHICH WERE SUCCESSFULLY DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 12953696 ↗
• MalfunctionNov 29, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SHAFT OF THE BURR WAS FOUND BROKEN. THE DEVICE WAS NOT USED INSIDE THE PATIENT WHEN THE ISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884717 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT THE BURR WAS FRACTURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR WAS UPSIZED TO 1.75MM, HOWEVER THE DEVICE WAS FRACTURED INSIDE THE ADVANCER AFTER THE SECOND RUN. THE DEVICE WAS REMOVED INTACT THROUGH THE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647640 ↗
• InjurySep 2, 2021Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND WAS SNARED TO REMOVE. THE 28MMX4.0MM MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SLIGHTLY CALCIFIED PROXIMAL AND MIDDLE RIGHT CORONARY ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE BURR WAS ADVANCED TO THE LESION, IN THE PROCESS OF HIGH SPEED GRINDING, THE BURR BECAME STUCK AND COULD NOT BE WITHDRAWN. THE PHYSICIAN CUT IT OFF AND GRABBED IT BACK WITH A SNARE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419014 ↗
• MalfunctionAug 24, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY(LAD). A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR BECAME STUCK IN THE LESION. IT WAS NOTED THAT SIGNIFICANT RESISTANCE WAS FELT UPON ADVANCING AND REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED DIRECTLY WITHOUT ANY ADDITIONAL INTERVENTION AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363398 ↗
• MalfunctionFeb 25, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09FEB2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 15MMX3.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.75MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE DISTAL END OF THE RELATED ROTAWIRE WAS STUCK AND PROTRUDING OUT OF THE BURR TIP, THE WIRE COULD NOT BE DISLODGED FROM THE ROTALINK BURR, AND SHEATH DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382347 ↗

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-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