RotaLink™ Burr H802227680030Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 08714729185857), received between Dec 12, 2016 and Sep 16, 2026 — classified as 3 deaths, 16 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (58 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 149 reports, 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 6, 2026Material Separation; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158621 ↗
• 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 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 25048061 ↗
• 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 25034495 ↗
• MalfunctionApr 16, 2026Material Separation; Infusion or Flow Problem; Noise, Audible

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION AS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE DEVICE DID NOT INDICATE ANY STALL AND SOUND WAS ROUGH. THE DEVICE HAD FRACTURED IN THE MIDDLE, AND FRONT OF THE BURR COULD NOT BE FLUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897252 ↗
• MalfunctionApr 15, 2026Entrapment of Device; Failure to Advance; Output Problem

  IT WAS REPORTED THAT BURR STUCK IN LESION OCCURRED. THE 25 MM LONG AND 100% STENOSED TARGET LESION, WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, WITH A VESSEL DIAMETER OF 3 MM. A 1.50MM ROTABLATOR WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR COULD NOT BE ROTATED AND GOT STUCK AT THE PROXIMAL AND COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885670 ↗
• MalfunctionApr 13, 2026Nonstandard Device; Deformation Due to Compressive Stress; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT A GUIDEWIRE RESTRICTION AND DEVICE KINKED OCCURRED. THE 28MM X 3.0MM IN DIAMETER, 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTABLATOR ROTALINK BURR WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE PUSH RESISTANCE WAS HIGH, THE DEVICE WAS KINKED AND COULD NOT BE IN PLACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED AS THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS DETACHED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865584 ↗
• MalfunctionDec 26, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE BURR WAS STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE BURR WAS STUCK OUTSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898865 ↗
• MalfunctionAug 28, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WHOLE SET OF SINGLE-USE DEVICE COULD NOT BE USED NORMALLY DUE TO THE ADVANCER WAS LEAKING GAS. THE PROCEDURE WAS CANCELLED. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WERE NO ISSUES WITH THE ROTALINK BURR, AND THAT THE PATIENT WAS SEDATED WITH LOCAL ANESTHESIA. IT WAS FURTHER REPORTED THAT THE BURR STALLED DUE TO THE ADVANCER LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916812 ↗
• 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 THE BURR CATHETER GOT FRACTURED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. THE PHYSICIAN NOTED THAT THE SPEED WAS SET AS REQUIRED AND WAS WITHIN THE SPECIFIED RANGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE BURR CATHETER GOT FRACTURED INSIDE THE PATIENT. THE DEVICE WAS REMOVED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD AND STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834530 ↗
• MalfunctionJun 17, 2025Decoupling; Detachment of Device or Device Component; Decoupling; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BURR DETACHMENT OCCURRED. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE PROBE OF THE BURR CATHETER WAS NOT IN PLACE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233525 ↗
• MalfunctionMay 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 1.50MM ROTALINK BURR AND A ROTAWIRE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE BURR WAS ON THE ROTAWIRE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTALINK BURR AND ROTAWIRE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073681 ↗
• MalfunctionMar 17, 2025Leak/Splash; Material Integrity Problem; Mechanical Jam; Output Problem; Material Split, Cut or Torn; Leak/Splash; Material Integrity Problem; Mechanical Jam; Output Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT CATHETER SALINE LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A RUPTURE AT THE PROXIMAL END OF THE CATHETER, AND THE WATER LEAKAGE WAS SERIOUS, RESULTING IN NO WATER FLOW FROM THE TIP OF THE CATHETER, A DECREASE IN SPEED, AND FRICTION WITH THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618782 ↗
• MalfunctionMar 7, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. THE 15 MM LONG AND 90% STENOSED TARGET LESION WAS LOCATED IN THE 3.00 MM MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 330CM ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE TIGHTENED UP AND KINKED. ALSO, THE BURR WAS STUCK ON WIRE AND COULD NOT BE WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548097 ↗
• MalfunctionFeb 12, 2025Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50 MM ROTALINK BURR AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. FURTHERMORE, THE GUIDEWIRE COULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. THE ROTAWIRE HAS REACHED THE LESION, BUT WHILE THE BURR WAS BEING ADVANCED, IT WAS FOUND THAT THE BURR COULD NOT CROSS THE ROTAWIRE, SO THE BURR DID NOT REACH THE INSIDE OF THE PATIENT. ADDITIONALLY, THE PHYSICIAN DIRECTLY REPLACED THE BURR, NOT USING OTHER DEVICES TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367861 ↗
• MalfunctionDec 31, 2024Connection Problem; Intermittent Loss of Power; Connection Problem; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE DEVICE COULD NOT BE CONNECTED AND WOULD STALL. THE 38MM X 3.0MM IN DIAMETER, 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TAIL OF THE BURR AND THE TIP OF THE ADVANCER COULD NOT BE CLOSELY CONNECTED AND WOULD STALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL AND SHEATH DETACHED ON THE PROXIMAL END. ALSO, THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048434 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT A BURR FRACTURE OCCURRED. THE 60MM X 3.5MM IN DIAMETER, 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE ADVANCER WAS CONNECTED, THE WIRE COULD NOT COME OUT FROM THE BURR. IT WAS THEN NOTED THAT THE BURR WAS FRACTURED 5CM FROM THE CONNECTION OF THE ADVANCER UPON OPENING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791989 ↗
• MalfunctionOct 31, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT ROTAWIRE WAS STUCK AT THE TAIL END OF THE BURR CATHETER AND THE SPRING AT THE BACK OF THE ROTARY GRINDING HEAD HAD CREASES. THE BURR AND WIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577492 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR, ROTALINK ADVACER W/ TUBULAR DRIVE SHAFT AND CONSOLE WERE SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CONSOLE CONNECTOR BROKE. THE PROCEDURE WAS CANCELLED WITHOUT COMPLICATIONS REPORTED, AND PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE CONNECTION METAL BETWEEN THE PEDAL AND THE CONSOLE WAS FRACTURED. THE PATIENT WAS SEDATED WITH A LOCAL ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837675 ↗

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-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