RotaLink™ Plus H749236310040Recalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 08714729228370), received between Nov 17, 2016 and May 12, 2026 — classified as 3 deaths, 23 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (51 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 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT THE BURR GOT DETACHED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR KEEPS COMING OFF AND THERE WAS A DOUBLE-ANGLED SECTION. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150241 ↗
• MalfunctionJan 14, 2026Device Markings/Labelling Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE LABELLING WAS INCORRECT. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING BRANCH. A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR CORONARY ARTERY STENT IMPLANTATION. DURING PROCEDURE, IT WAS FOUND THAT THE BURR WAS TOO SMALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071396 ↗
• MalfunctionOct 7, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE BURR COULD NOT BE LOADED ON THE GUIDE WIRE. A 1.75MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR ROTATIONAL ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR COULD NOT BE LOADED ON THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PORTION OF A ROTAWIRE WAS STUCK WITHIN THE DISTAL END OF THE BURR AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234499 ↗
• MalfunctionJun 30, 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 MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE 1.5 BURR GOT STUCK IN THE LESION. THE SPEED WAS AT 180,000 RPM BUT THE ACTUAL SPEED WAS ONLY AT 120,000 RPM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365857 ↗
• MalfunctionJun 25, 2025Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT A BURR AND GUIDEWIRE ENTANGLEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING BRANCH. A 1.75MM ROTABLATOR ROTALINK PLUS AND A 330CM ROTAWIRE WERE SELECTED FOR USE. DURING PREPARATION, THE ROTATIONAL SPEED WAS TESTED NORMALLY; HOWEVER, THE ROTAWIRE COULD NOT ROTATE WITH THE BURR, BUT THE BURR ROTATED NORMALLY, AND THE ADVANCER MOVED NORMALLY. UPON ENTERING THE PATIENT'S BODY, THE BURR WAS ABLE TO MOVE FORWARD NORMALLY IN THE GUIDING CATHETER AND WAS NEARLY DELIVERED OUT OF THE GUIDING CATHETER PORT. HOWEVER, IT WAS NOTED THAT THE DEVICES WERE ENTANGLED AND THE TEST WAS CONDUCTED IN VITRO. THE ROTAWIRE AND BURR WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331166 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WAS DETACHED. A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OLIVE CAME LOOSE FROM THE BODY OF THE ROTALINK CATHETER AND BECAME LOOSE IN THE PATIENT'S CORONARY ARTERY. IT WAS RECAPTURED BY ADVANCING THE ROTAWIRE GUIDE UNTIL REACHING THE 0.14 PART OF THE GUIDE AND MANAGING TO "FISH" THE OLIVE THAT WAS LOOSE IN THE CORONARY ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160647 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BURR BROKE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING PRE-TESTING, IT WAS NORMAL TO INCREASE THE SPEED; HOWEVER, AFTER USING THE DEVICE, IT WAS NOTED THAT THE FRONT OF THE BURR BROKE. THE DEVICE WAS REMOVED ALL SYSTEM AS USUAL STEP. 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 21874464 ↗
• MalfunctionNov 4, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09OCT2024. IT WAS REPORTED THAT THE KINKING DUE TO ANGULATION WHEN CROSSING THE LESION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT KINKING DUE TO ANGULATION WHEN CROSSING THE LESION OCCURRED. 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 WAS DETACHED AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598087 ↗
• MalfunctionAug 8, 2024Material Deformation; Intermittent Loss of Power; Material Deformation; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS KINKED DUE TO ANGULATION WHEN CROSSING THE LESION AND IT GOT STALLED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944737 ↗
• DeathDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED FOR A COMPLEX LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY (LAD) CROSSOVER PROCEDURE. IT WAS NOTED THAT THE LEFT MAIN WAS SEVERELY TORTUOUS AND HEAVILY CALCIFIED. A 1.75MM ROTALINK ROTABLATOR PLUS WAS USED FOR TWO RUNS OF 11 SECONDS TO ABLATE THE CALCIUM, THEN A WOLVERINE 3.0 X 10MM AND A SYNERGY 3.0 X 32MM WERE USED TO TREAT THE LESION; BOTH WERE INFLATED AT 11 ATM. AFTERWARDS, ANGIO REVEALED TIMI3 FLOW WITHOUT ANY DISSECTION. AFTER ANGIO, HOWEVER, THE PATIENT WENT INTO CARDIAC ARREST AND WAS IMMEDIATELY MOVED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFT SURGERY. THE PATIENT PASSED AWAY THE NEXT DAY DUE TO CARDIAC TAMPONADE WHICH LED TO CARDIOGENIC SHOCK.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Cardiogenic Shock

  MAUDE report 18415165 ↗
• MalfunctionDec 21, 2022Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT THE DEVICE HAD STERILITY ISSUES. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THERE WAS AN OPENING IN THE INNER PACKAGE, AND IT WAS NOT CERTAIN WHETHER THE DEVICE WAS STILL STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025453 ↗
• MalfunctionJul 7, 2022Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 24MM X 4.00-4.80MM, 70-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 330 CM ROTAWIRE AND WIRECLIP TORQUER AND A 1.75 MM ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC 7FR GUIDE CATHETER WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE WERE USED TO CANNULATE THE CALCIFIED RIGHT CORONARY ARTERY BUT COULD NOT ADVANCE DISTALLY, SO A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO PROVIDE BETTER SUPPORT. THEN, A ROTAWIRE GUIDEWIRE WAS ADVANCED THROUGH THE MICROCATHETER AND THE 1.75 MM ROTALINK PLUS WAS DELIVERED TO ABLATE THE MID-RIGHT CORONARY ARTERY. AFTER ABLATION WAS CARRIED OUT SUCCESSFULLY FOR THREE RUNS, THE ROTALINK PLUS WAS REMOVED FROM THE MICROCATHETER. AS THE ROTALINK PLUS WAS REMOVED VIA DYNAGLIDE MODE, IT WAS NOTED THAT THE ROTAWIRE WAS KINKED, THE STALLED OPTION APPEARED, AND THE ROTA SYSTEM (ROTALINK PLUS AND ROTAWIRE) WERE STUCK TOGETHER AND COULD NOT BE REMOVED PNEUMATICALLY. THE WHOLE SYSTEM WAS MANUALLY REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF SAME DEVICE. NO CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950350 ↗
• DeathJun 13, 2022Entrapment of Device; Detachment of Device or Device Component; Output Problem; Entrapment of Device; Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT A DEATH OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA). PATIENT WAS ADMITTED FOR ROTABLATION PROCEDURE FOR RIGHT CORONARY ARTERY (RCA), THE SURGERY HAD BEEN DELAYED BY WEEKS AS PATIENT HAD A PREVIOUS BLEED NOT RELATED TO PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE PATIENT WAS FRAIL AND HIGH RISK FOR BLEEDS. A CORONARY ARTERY BYPASS GRAFTING (CABG) WAS NOT SEEN AS AN OPTION. UPON TRYING TO ENGAGE THE RCA, IT WAS CHALLENGING, UNUSUAL ANATOMY WHICH LEAD TO TEN GUIDES BEING USED BUT NONE THAT WOULD ENABLE ADEQUATE SUPPORT FOR A ROTABLATOR PLUS. AFTER TWO HOURS. THE PROCEDURE WAS ABANDONED WITH PLANS TO BRING THE PATIENT BACK BECAUSE THE HOSPITAL DID NOT HAVE A GUIDE ON SITE. THE LAD WAS ALSO DISEASED SO THE PHYSICIAN PROGRESSED WITH A STAGED PROCEDURE TO TREAT THIS VESSEL. A 2.50 EMERGE BALLOON WAS USED IN THE LAD THEN, AN INTRAVASCULAR ULTRASOUND (IVUS) PERFORMED, SHOWED DIFFUSE DISEASE, CALCIFICATION AND A VESSEL MEASUREMENTS OF 3.50MM. A 3.0X12 NC BALLOON WAS USED, IT WAS UNABLE TO GET ADEQUATE PREP OF VESSEL, THEN THEY USED A 3.0X15MM W

  Patient problems: Foreign Body In Patient; Low Blood Pressure/ Hypotension

  MAUDE report 14680368 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND ST ELEVATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY WITH A 2.75MM VESSEL DIAMETER. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WANTED TO DO ONE LAST ROUND OF POLISHING, HOWEVER, THE PATIENT WENT INTO MI AND ST ELEVATION. THE PHYSICIAN REMOVED THE DEVICE AND PERFORMED CARDIOPULMONARY RESUSCITATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PATIENT IS STABLE.

  Patient problems: Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 14604116 ↗
• MalfunctionJan 28, 2022Detachment of Device or Device Component; Output Problem; Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT BURR SEPARATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOSITY AND MILDLY TO MODERATELY CALCIFIED THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX). A 1.75MM ROTABLATOR PLUS WAS SELECTED FOR THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE ROTABLATOR WAS PREPPED AND PLATFORMED AT 180000 RPM OUTSIDE THE PATIENT. DURING ADVANCEMENT, THERE WAS NO RESISTANCE. AFTER ABLATION SUCCESSFULLY COMPLETED, THE PHYSICIAN NOTED THAT THE BURR BECAME SEPARATED FROM THE SHAFT WHILE THE BURR WAS STILL INSIDE THE PATIENT. THERE WAS A DEGREE OF DECELERATION AND DEVICE STALL PRIOR TO BECOMING DETACHED. THE DEVICE WAS PULLED OUT WITH THE ROTAWIRE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385598 ↗
• MalfunctionJan 19, 2022Detachment of Device or Device Component; Gas/Air Leak; Output Problem; Detachment of Device or Device Component; Gas/Air Leak; Output Problem

  IT WAS REPORTED THAT THE DEVICE GOT SEPARATED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL AND MIDDLE THIRD OF ANTERIOR DESCENDING ARTERY. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN FIRST USED A 1.50MM ROTALINK PLUS WITHOUT ANY PROBLEM. THEN THEY REQUESTED TO USE THE 1.75MM ROTALINK PLUS AS EITHER THE DA VESSEL WAS CALCIFIED OR THEY JUST WANT TO EXCHANGE TO A LARGER OLIVE SIZE. WHEN A DRAW TEST WAS PERFORMED OUTSIDE THE PATIENT, THE ROTATION SPEED WAS UNSTABLE. WHEN THE PEDAL WAS ACTIVATED AT THE SPEED OF 160,000RPM, IT LATER DROPPED TO 120-110,000RPM SHARPLY. THE CONNECTORS WERE CHECKED SEVERAL TIMES IF THEY WERE PROPERLY IN PLACE. HOWEVER, THE PHYSICIAN FELT A SLIGHT LEAK IN THE LOWER PART OF THE DEVICE. UPON WITHDRAWAL, THE 1.75MM ROTALINK PLUS GOT SEPARATED AND THE PHYSICIAN OPTED TO USED ONLY THE 1.50MM ROTALINK PLUS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289137 ↗
• MalfunctionNov 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE WIRE GOT STUCK WITHIN THE BURR. THE TARGET LESION WAS LOCATED IN THE MILDLT TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR ARTERY. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE GOT STUCK IN THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE ADVANCER, HANDSHAKE CONNECTIONS, SHEATH, COIL, BURR AND ANNULUS WERE VISUALLY AND MICROSCOPICALLY EXAMINED. INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO REMOVE THE RETURNED ROTAWIRE, AND THE RETURNED ROTAWIRE WAS ABLE TO BE REMOVED WITHOUT ISSUES. THE RETURNED ROTAWIRE WAS THEN ABLE TO BE REINSERTED AND PASSED THROUGH THE DEVICE WITH NO RESISTANCE OR ISSUES. PRODUCT ANALYSIS WAS NOT ABLE TO CONFIRM THE REPORTED EVENTS, AS THE RETURNED ROTAWIRE WAS ABLE TO BE REMOVED FROM AND REINSERTED INTO THE ROTABLATOR DEVICE WITH NO RESISTANCE OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865067 ↗
• MalfunctionAug 16, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT A GUIDEWIRE DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTAWIRE DRIVE AND A 1.75MM ROTALINK PLUS WERE SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION. THE GUIDEWIRE WAS INSERTED WITH A MICROCATHETER. DURING THE PROCEDURE, THE BURR WAS ROTATING AT A SPEED OF 190,000 FOR 30 SECONDS WHEN THE GUIDEWIRE SPRING TIP FRACTURED. SINCE IT IS PERIPHERAL, THE GUIDEWIRE WAS LEFT AS IT WAS, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324969 ↗
• MalfunctionJul 27, 2021Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  IT WAS REPORTED GUIDEWIRE ENTRAPMENT OCCURRED. A 1.75MM ROTALINK PLUS AND ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR A CORONARY ANGIOGRAPHY AND INTERVENTRICULAR ANGIOPLASTY PROCEDURE WITH ACTIVE STENT PLACEMENT. DURING THE BEGINNING OF THE PROCEDURE, THE GUIDEWIRE BECAME BLOCKED AND WAS UNABLE TO PASS THROUGH THE ROTALINK PLUS. THE GUIDEWIRE ROTATES WHEN THE MOTOR IS TURNED ON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233154 ↗
• MalfunctionJul 24, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BREAK LOCK FAILED TO HOLD THE GUIDEWIRE. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE ROTATION, IT WAS NOTED THAT THE ROTAWIRE LOOSENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222622 ↗
• MalfunctionMay 10, 2021Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. A 1.75MM ROTALINK PLUS WAS SELECTED FOR SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. DURING THE PROCEDURE, A PECKING MOTION WAS USED FOR ADVANCEMENT AND THE ROTALINK WAS ADVANCED. THE DEVICE WAS TRIED TO RETRIEVE IN DYNAGLIDE MODE BUT IT WAS DIFFICULT TO REMOVE FROM THE PATIENT. THE PHYSICIAN THEN REMOVED THE DEVICE BY HARD PULLING THE DEVICE. AFTER IT WAS REMOVED, THE PHYSICIAN NOTICED THE BURR WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTALINK PLUS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801009 ↗
• MalfunctionApr 5, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK ON ROTAWIRE. A 1.75MM ROTALINK PLUS AND ROTAWIRE (EXTRA SUPPORT) WERE SELECTED FOR USE. AFTER ABLATION, THE BURR WAS REMOVED. HOWEVER, IT GOT STUCK WITH THE GUIDEWIRE. THE DEVICES WERE REMOVED FROM THE PATIENT TOGETHER AS ONE UNIT, THEN THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616185 ↗
• MalfunctionFeb 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 1.75MM ROTALINK PLUS AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WAS SEVERELY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. DURING WITHDRAWAL WHILE IN DYNAGLIDE MODE, THE BURR BECAME STUCK ON THE WIRE. THE ROTALINK PLUS COULD NOT BE PULLED BACK, SO BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369350 ↗
• MalfunctionJan 22, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTATION SPEED WAS NOT STABLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11214575 ↗
• MalfunctionJan 14, 2021Difficult to Remove; Intermittent Loss of Power; Difficult to Remove; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. AFTER THE ABLATION WAS COMPLETED, THE STALL LAMP WAS TURNED ON DURING DYNAGLIDE MODE AND THE DEVICE COULD NOT BE REMOVED. SO, BOTH ROTAWIRE AND ROTABURR WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11172639 ↗

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