RotaLink™ Plus H749236310020Recalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 08714729316411), received between Nov 16, 2016 and Aug 7, 2026 — classified as 11 deaths, 54 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (105 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Mechanical Problem

  It was reported that failure to lock on wire occurred. The 90% stenosed, 32 mm long target lesion was located in the moderately tortuous and severely calcified left anterior descending artery with a vessel diameter pf 3.5 mm. A 1.25mm Rotablator Plus and RotaWire were selected for use. During procedure, it was noted that after the burr stopped rotating at a low speed upon reaching 1-2cm from the lesion site, the guide wire moved backward with unknown reasons. The device was replaced. The procedure was completed with another of the same device. There were no patient complications, and the patient condition was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181030 ↗
• MalfunctionJul 16, 2026Nonstandard Device; Deformation Due to Compressive Stress; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2026. IT WAS REPORTED THAT DEVICE WAS KINKED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS NOTED TO BE KINKED DUE TO ANGULATION WHEN CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847621 ↗
• MalfunctionMar 31, 2026Nonstandard Device; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAR2026. IT WAS REPORTED THAT THE DEVICE STALLED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR CONTINUOUSLY STALLED WHEN PRESSING THE FOOT PEDAL DESPITE RUNNING WITH SALINE AND ALL PRESSURES BEING NORMAL FOR THE NITROGEN CYLINDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BURR WAS DETACHED AND THE FULL LENGTH OF THE COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745158 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED THAT WATER LEAKAGE WAS OBSERVED AT THE MIDDLE OF THE SHAFT. A 1.25MM ROTALINK? PLUS WAS SELECTED FOR TREATMENT OF THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION, WATER LEAKAGE WAS OBSERVED AT THE MIDDLE SECTION OF THE SHAFT INSTEAD OF THE NORMAL DRIP AT THE REAR END OF THE DEVICE. THE GUIDEWIRE CROSSED THE TIP OF THE DEVICE BUT COULD NOT SMOOTHLY EXIT THE TAIL END. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE BURR. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554633 ↗
• DeathMar 2, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 1.25MM ROTABLATOR PLUS AND 330CM ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHILE DOING ROTATIONAL ATHERECTOMY ANGIOPLASTY, THE BURR STUCK AND INDUCED A PERFORATION, WHICH CAUSED THE PATIENT TO EXPIRE.

  Patient problems: Perforation

  MAUDE report 24484630 ↗
• MalfunctionFeb 27, 2026Failure to Advance; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.25MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING TEST OUTSIDE THE PATIENT, THE ROTATION SPEED DID NOT GO UP, AND IT HAD ABNORMAL SOUND. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473960 ↗
• MalfunctionFeb 18, 2026Nonstandard Device; Material Separation; Noise, Audible

  IT WAS REPORTED THAT BURR FRACTURE OCCURRED. THE 80% TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX BRANCH. A 1.25MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BURR MADE AN ABNORMAL SOUND, AND AFTER IT WAS WITHDRAWN FROM THE BODY, THE BURR WAS FRACTURED AND ONLY A WIRE OF CONNECTION WAS LEFT. THE DEVICE WAS SIMPLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380545 ↗
• MalfunctionDec 24, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.25MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT ROTAWIRE WAS UNABLE TO BE ADVANCED, RESULTING IN FAILURE TO PERFORM THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889425 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19SEP2025. IT WAS REPORTED THAT THE WALL OF THE CATHETER WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MIDDLE SEGMENT OF LEFT ANTERIOR DESCENDING ARTERY. A 1.25 MM ROTABLATOR PLUS WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE WALL OF THE CATHETER WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN AT 41CM FROM THE DISTAL TIP OF THE SHEATH WITH BLOOD PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301393 ↗
• MalfunctionSep 11, 2025Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT ROTABURR WAS STUCK WITH THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ROTAWIRE WAS STUCK WITH THE ROTABURR AND FRACTURED. 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 23032029 ↗
• MalfunctionAug 12, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUL2025. IT WAS REPORTED THAT THE BURR FAILED TO ADVANCE THE LESION. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, THE DOCTOR WAS TRYING TO BURR THE CALCIFIED LESION IN RCA BUT SOMEHOW THE ROTABLATION WAS NOT IMPACTFUL. THE DOCTOR THEN DECIDED TO GO WITH IVL AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS WORN AND TORN. THE COIL WAS DETACHED AT 1.5CM DISTAL FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787049 ↗
• MalfunctionJul 30, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A 1.25M ROTABLATOR ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ROTABLATOR BURR CAUGHT THE ROTAWIRE. REPLACING THE ROTAWIRE DID NOT RESOLVE THE ISSUE, BUT REPLACING THE ROTABLATOR BURR DID. THE SAME ROTAWIRE WAS USED WITH THE SECOND ROTABLATOR AND NO DAMAGES WERE NOTED ON THE ROTAWIRE. THE ROTAWIRE AND BURR WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED, AND PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669199 ↗
• MalfunctionJun 17, 2025Entrapment of Device; Nonstandard Device; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Output Problem; Intermittent Loss of Power; Entrapment of Device; Nonstandard Device; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING BRANCH. A 1.25MM ROTABLATOR ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USED. DURING THE PROCEDURE, UPON IN VITRO TEST, THE SPEED WAS SET TO 148,000 RPM AND A 144,000 MAXIMUM SPEED WAS OBSERVED. DURING ADVANCEMENT, SIGNIFICANT RESISTANCE WAS FELT, AND THE DEVICE COULD NOT BE ADVANCED. IT WAS NOTED THAT THE BURR AND THE ROTAWIRE BECAME STUCK TOGETHER AND A STALL WAS INDICATED. THE BURR WAS UNABLE TO BE ADVANCED INTO THE LESION SITE AND COULD NOT BE WITHDRAWN EVEN AFTER SWITCHING BETWEEN HIGH AND LOW SPEEDS. THE ROTAWIRE AND THE ENTIRE DELIVERY SYSTEM OF THE BURR WERE PULLED OUT TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233361 ↗
• MalfunctionJun 11, 2025Entrapment of Device; Nonstandard Device; Failure to Advance; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power; Entrapment of Device; Nonstandard Device; Failure to Advance; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE ROTALINK PLUS WAS INSERTED BUT THE LAD VESSEL WAS TOO TORTUOUS, AND IT WAS THOUGHT THAT THE BURR COULD BE STUCK IN THE CALCIUM DUE TO VESSEL TORTUOSITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186161 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  IT WAS REPORTED THAT A CATHETER SALINE LEAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. BEFORE THE DRAW TEST, DURING THE ROTATIONAL CHECK, THE TEST COULD NOT BE COMPLETED. WHEN ROTATION WAS SWITCHED ON, A SUDDEN, DIFFERENT NOISE OCCURRED, AND THEN THE MACHINE AUTOMATICALLY WENT INTO DYNA MODE AND SHUT OFF. A SALINE LEAK WAS THEN OBSERVED, BUT THE LOCATION OF THE LEAK WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME BRAND. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160061 ↗
• InjuryMay 19, 2025Entrapment of Device; Nonstandard Device; Output Problem; Entrapment of Device; Nonstandard Device; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. THE PATIENT UNDERWENT A PROCEDURE TO TREAT A LESION IN THE MID-LEFT ANTERIOR DESCENDING (MID LAD) ARTERY, WHICH WAS TORTUOUS AND HEAVILY CALCIFIED. A 1.25 MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. AFTER A SUCCESSFUL DRAW TEST, THE PHYSICIAN CLEARED THE PROXIMAL SIDE OF THE LESION. HOWEVER, DURING A SECOND ATTEMPT, THE BURR BECAME STUCK IN THE LESION, ACCOMPANIED BY A LARGER DROP IN RPM. TO ENSURE PATIENT SAFETY, THE DEVICE WAS WITHDRAWN. THE ATTENDED PHYSICIAN THEN USED SMALL PROFILE BALLOONS, A CUTTING BALLOON, AND PLACED STENTS TO FINISH THE PROCEDURE. THE PATIENT HAD SOME PAIN AND DISCOMFORT AFTER THE PROCEDURE AND WAS STABILIZED WITH NITROGLYCERIN (NTG).

  Patient problems: Discomfort; Pain

  MAUDE report 22049214 ↗
• MalfunctionMay 2, 2025Failure to Advance; Failure to Advance

  BASED ON DEVICE ANALYSIS COMPLETED ON 11APR2025. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE 79% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE FAILED TO PASSAGE THE LESION. 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 SHEATH WAS TORN APART AT 45.2CM DISTAL FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951555 ↗
• MalfunctionMar 24, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24FEB2025. IT WAS REPORTED THAT THE BURR COULD NOT CROSS LESION. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). IT WAS NOTED THAT THE BURR COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND PATIENT WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE WIRE WAS FROZE WITHIN THE BURR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679140 ↗
• MalfunctionFeb 20, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BRAKE MALFUNCTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. WHILE PREPARING THE DEVICE, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE BRAKE OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING 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 21426529 ↗
• MalfunctionFeb 10, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL AND MIDDLE SEGMENTS OF THE LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR TOUCHED THE STERILE CLOTH. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE, AND PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21350065 ↗
• MalfunctionFeb 5, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN USED THE DEVICE, IT BECAME STUCK IN THE LESION. THE DEVICE PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313755 ↗
• MalfunctionJan 8, 2025Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Output Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THAT ROTATION SPEED WAS UNSTABLE. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, A LOUD NOISE OF AIR LEAKING WAS HEARD DURING THE PRESSURE TEST AND THE ADVANCER WAS DIFFICULT TO HANDLE. WHEN THE BURR ROTATION WAS ADJUSTED, THE ROTATION FREQUENCY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102837 ↗
• MalfunctionDec 30, 2024Entrapment of Device; Material Deformation; Mechanical Jam; Entrapment of Device; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTA BURR WAS UNABLE TO TRACK ACROSS THE ROTAWIRE AND GOT STUCK AFTER 2 TO 3 ROUNDS OF BURRING. ALSO, A KINK WAS NOTED ON THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21041280 ↗
• MalfunctionOct 15, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON GUIDEWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MAIN ARTERY. A 1.25MM ROTABLATOR PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK ON WIRE. 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 20450319 ↗
• MalfunctionOct 7, 2024Output Problem; Output Problem

  REPORTABLE BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 12SEP2024. IT WAS REPORTED THAT THE DEVICE FAILED TO REACH THE NORMAL SPEED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 1.25MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR COULD NOT REACH THE NORMAL SPEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL AND BURR WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384761 ↗

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