ROTAPRO™ H74939309010Recalls & reported problems
Boston Scientific Corporation · Rotational Atherectomy System · Class 3
Quick summary
This Boston Scientific Rotapro device is a rotational atherectomy catheter used in coronary procedures. The 41 reports mostly describe console or speed instability and related malfunctions, including one death and no injuries. There is one closed recall, started November 2021, about missing directions not to retest a pneumatic kit component. Reports fell to 2 in the last 12 months from 7 the previous year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729975076), received between Nov 19, 2018 and Jun 26, 2026 — classified as 1 death, 40 malfunctions.
The most frequently reported specific device problem is “Output Problem” (22 reports).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 8, 2021Terminated
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Z-0381-2022 · Root cause: Employee error · FDA record ↗
Most reported problems
Device problems
- Output Problem22
- Unstable14
- Display or Visual Feedback Problem5
- Gas/Air Leak3
- Mechanics Altered3
- No Display/Image3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient3
- Arrhythmia1
- Bradycardia1
- Cardiac Arrest1
- Chest Pain1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Output Problem
IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE ROTAPRO WAS UNABLE TO OPERATE IN DYNAGLIDE MODE. THE PROCEDURE WAS CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636482 ↗MalfunctionMar 23, 2026Mechanics Altered; Optical Problem; Output Problem
IT WAS REPORTED THAT AN ERRATIC SPEED OCCURRED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SPEED WAS SET TO 180K RPM; HOWEVER, THE CONSOLE DISPLAYED A SPEED OF 230K RPM AND COULD NOT BE DECREASED. THE DEVICE SOUNDED LIKE IT WAS ROTATING FASTER THAN THE SET SPEED. DYNAGLIDE MODE WAS ACTIVATED AND THE BURR WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A CUTTING BALLOON. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663630 ↗MalfunctionOct 21, 2025Unstable; Output Problem; Unstable; Output Problem
IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, BURR IS SPINNING AT A HIGHER SPEED THAN NORMAL. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT ACTUAL SPEED OBSERVED WAS 135,000 RPM IN DYNAGLIDE MODE. THE DEVICE SOUNDED FAST IN DYNAGLIDE MODE AND WAS THOUGHT TO BE SPINNING FASTER THAN INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353901 ↗MalfunctionOct 21, 2025Unstable; Unstable
IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, BURR IS SPINNING AT A HIGHER SPEED THAN NORMAL. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351975 ↗MalfunctionJun 30, 2025Unstable; Defective Device; Adverse Event Without Identified Device or Use Problem; Output Problem; Unstable; Defective Device; Adverse Event Without Identified Device or Use Problem; Output Problem
IT WAS REPORTED THAT THE SPEED SURPASSED THE SET ROTATIONAL SPEED. A ROTAPRO CONSOLE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE SPEED WAS SET TO 150,000 RPM, HOWEVER THE MAXIMUM OBSERVED ROTATIONAL SPEED REACHED UP TO 164,000 RPM IN NORMAL MODE AND DYNAGLIDE MODE. TRIED TO DYNAGLIDE THE SPEED BUT WOULD NOT LOWER TO 60,000 RPM EVEN WITH DIFFERENT BURR SIZES. THE CATHETER WAS REMOVED FROM THE BODY AND THE POWER WAS TURNED ON AND OFF ON THE CONSOLE. ROTA WAS PLATFORMED OUTSIDE THE BODY AND CATHETER REINSERTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366905 ↗MalfunctionMar 21, 2025Unstable; Output Problem; Unstable; Output Problem
IT WAS REPORTED THAT AN UNSTABLE SPEED OCCURRED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE CONSOLE HAD HIGH REVOLUTIONS PER MINUTE (RPM) AND IT WAS EXPECTED THAT THE RPMS SHOULD CUT IN HALF. HOWEVER, THE RPMS REMAINED HIGH AND THE CYCLE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE ISSUE WAS OBSERVED DURING IN-SERVICE AND IN DYNAGLIDE MODE. THE PROCEDURAL TARGET SPEED WAS 160,000 RPM HOWEVER CONSOLE WOULD ONLY INCREASE TO 130,000 RPM. THE SET ROTATIONAL SPEED WAS AT 130,000 RPM AND REACHED A MAXIMUM SPEED OF 134,000 RPM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662912 ↗MalfunctionMar 3, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTAPRO CONSOLE WERE SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE SPEED REMAINED AT 140K WHEN THE DYNAGLIDE MODE WAS ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21508044 ↗MalfunctionJan 27, 2025No Display/Image; Mechanics Altered; No Display/Image; Mechanics Altered
IT WAS REPORTED THAT A DISPLAY ISSUE OCCURRED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE EQUIPMENT SCREEN WAS NOT MARKING THE CORRECT REVOLUTIONS OF THE BURR. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21246318 ↗MalfunctionJan 24, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTAPRO CONSOLE KIT ASSY UL/ CSA WAS SELECTED FOR USE. DURING PLATFORMING, THE RPM IS NOT STABILIZING AND IS GOING FASTER AND SLOWER WITHOUT ANY ENGAGEMENT. THE PROCEDURE WAS ABORTED. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER MODALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233145 ↗MalfunctionOct 21, 2024Output Problem; Output Problem
IT WAS REPORTED THAT SPEED IS UNABLE TO BE ADJUSTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO ROTAPRO CONSOLE KIT ASSY UL/ CSA WERE SELECTED FOR USE. DURING THE PROCEDURE, THE RPM READ OUT FOR DYNAGLIDE WAS AT 150,000 RPM. ALSO, IT WAS NOTED THAT THE SPEED CONTROL IS NOT WORKING AND THE SPEED CANNOT BE ADJUSTED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494560 ↗MalfunctionSep 12, 2024Unstable; Mechanics Altered; Intermittent Loss of Power; Unstable; Mechanics Altered; Intermittent Loss of Power
IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 1.50MM, 1.25MM ROTAPRO AND CONSOLE WERE SELECTED FOR USE. DURING PREPARATION, THE 1.50MM BURR STALLED BRIEFLY. WHEN IT WENT INTO THE PATIENT WITH A SET SPEED OF 165K. THE SPEED REACHED AT A MAXIMUM OF 200K, AND IT STALLED MULTIPLE TIMES AND WOULD NO LONGER RUN AS IT STUCK IN THE PROXIMAL LESION. THE DEVICE WAS REMOVED FROM THE BODY AND WAS CHANGED TO A 1.25 BURR. WHEN PLACED PRIOR TO THE LESION AT A SET SPEED OF 165K. THE ROTATION SPEED PER MINUTE (RPM) APPEARED ON THE SCREEN WITH A MAXIMUM 0F 220K, BUT NO SOUND OF THE BURR WAS HEARD, AND NO STALLED SIGNAL WAS ON. THE BURR WAS ALSO GOT STUCK IN THE LESION. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THE PROCEDURE GOT PROLONGED, BUT NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20206075 ↗MalfunctionJun 14, 2024Unstable; Unstable
IT WAS REPORTED THAT THE SPEED SHIFTED ON ITS OWN. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SYSTEM SHIFTED FROM DYNAGLIDE MODE TO CUTTING MODE RPM ON ITS OWN TWICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536426 ↗MalfunctionApr 3, 2023Defective Device; Defective Device
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTAPRO WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE UNIT WILL NOT GO INTO DYNAGLIDE. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16668044 ↗MalfunctionNov 16, 2021Unstable; Unstable
IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED AND THE PROCEDURE WAS CANCELLED. A ROTAPRO CONSOLE WAS SELECTED FOR USE. ROTAPRO ROTATIONAL SPEED WAS INCONSISTENT DURING USE WHILE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820672 ↗MalfunctionSep 8, 2021No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CONSOLE SCREEN FLICKERED THEN FADED TO BLACK. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING START UP AND DURING THE PROCEDURE, THE CONSOLE SCREEN FLICKERED AND FADED TO BLACK. THE PROCEDURE WAS COMPLETED WITH A 1.5 BURR. THE PATIENT'S STATUS WAS OKAY POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443268 ↗MalfunctionSep 8, 2021No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CONSOLE SCREEN FLICKERED THEN FADED TO BLACK. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING START UP AND DURING THE PROCEDURE, THE CONSOLE SCREEN FLICKERED AND FADED TO BLACK. THE PROCEDURE WAS COMPLETED WITH A 1.5 BURR. THE PATIENT'S STATUS WAS OKAY POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443264 ↗DeathJul 14, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A CATHETER ROTATION WOULD NOT STOP RESULTING IN THE PATIENT BEING SENT TO THE INTENSIVE CARE UNIT. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED TO THE CIRCUMFLEX TO EVALUATE THE BLOCKAGE. THE CATHETER TIP THEN BECAME STUCK IN THE BLOCKAGE. THE OPTICROSS WAS ATTEMPTED TO BE WITHDRAWN. FORCE WAS APPLIED TO REMOVE THE CATHETER AND THE DISTAL TIP DETACHED INSIDE THE BLOCKAGE WITHIN THE CIRCUMFLEX. RETRIEVAL ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED TIP. A 1.5MM ROTAPRO BURR CATHETER WAS USED TO ABLATE A PATH TO REACH THE DETACHED TIP. WHILE ATHERECTOMY WAS BEING PERFORMED IN THE ARTERY THE SYSTEM COULD NOT STOP ROTATING. THE POWER WAS TURNED OFF ON THE ROTAPRO CONSOLE. SUBSEQUENTLY, THE PATIENT CODED. THE PATIENT LOST THEIR LEFT ANTERIOR DESCENDING ARTERY AND A PSEUDOANEURYSM FORMED IN THE PROXIMAL AREA OF THE CIRCUMFLEX ARTERY. A LEFT VENTRICULAR ASSIST DEVICE WAS PLACED INSIDE THE PATIENT AND THE LEFT ANTERIOR DESCENDING ARTERY WAS STENTED WITHOUT ISSUE. THE PATIENT STABILIZED AND WAS SENT TO THE INTENSIVE CARE UNIT. IT WAS FURTHER REPORTED THAT THE PATIENT DIED.
Patient problems: Arrhythmia; Bradycardia; Cardiac Arrest; Chest Pain; Foreign Body In Patient; Insufficient Information; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pseudoaneurysm
MAUDE report 12170421 ↗MalfunctionApr 8, 2021Unstable; Unstable
IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTAPRO CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE THE SPEED WAS UNSTABLE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11633803 ↗MalfunctionMar 9, 2021Mechanical Problem; Output Problem; Noise, Audible; Mechanical Problem; Output Problem; Noise, Audible
IT WAS REPORTED THAT ROTATION SPEED WAS UNSTABLE. A 1.50MM ROTAPRO AND A ROTAPRO CONSOLE WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION TO TREAT CORONARY ARTERY DISEASE. DURING THE PROCEDURE, THE SPEED WAS SET TO 160,000 ROTATIONS PER MINUTE (RPM), BUT THE BURR WAS NOT MAINTAINING A CONSISTENT SPEED. THE SPEED WOULD FALL BELOW 160,000 RPM AND JUMP OVER 200,000 RPM. WHILE IN DYNAGLIDE MODE DURING THE FIRST ABLATION, AN INTERMITTENT JUMPING NOISE WAS HEARD FROM THE ADVANCER, AND THE DEVICE WOULD STALL. CONNECTIONS WERE CHECKED, BUT THE 1.50MM ROTAPRO WAS ULTIMATELY EXCHANGED FOR ANOTHER. THE ERRORS RESOLVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11449405 ↗MalfunctionFeb 26, 2021Unstable; Output Problem; Unstable; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND RESCHEDULED POST SEDATION. TWO 1.50MM ROTAPRO CATHETERS AND A ROTAPRO CONSOLE WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE PATIENT WAS SEDATED. DURING PREPARATION, THE FIRST 1.50MM ROTAPRO STARTED AT A ROTATION SPEED OF 250,000 ROTATIONS PER MINUTE (RPM), BUT THE BURR SOUNDED VERY SLOW. IT ALSO SOUNDED LIKE THE SPEED WAS FLUCTUATING UP AND DOWN AS IF THE DEVICE WAS WORKING HARDER THAN USUAL. THE SPEED ON THE CONSOLE REMAINED AT 250,000 RPM THIS ENTIRE TIME. THE SYSTEM WAS DISCONNECTED AND RECONNECTED, THE GAS PRESSURE WAS CHECKED, AND THE SYSTEM WAS TURNED BACK ON. THE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME. THE SECOND 1.50MM ROTAPRO STARTED AT 170,000 RPM THEN QUICKLY DROPPED TO 150,000 RPM. THE BURR SOUNDED LIKE THE FIRST DEVICE DID. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR FEBRUARY 22, 2021. NEITHER CATHETER EVER ENTERED THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385859 ↗MalfunctionFeb 25, 2021Output Problem; Noise, Audible; Output Problem; Noise, Audible
IT WAS REPORTED THAT ROTATION SPEED WAS UNSTABLE. A 1.50MM ROTAPRO AND A ROTAPRO CONSOLE WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION TO TREAT CORONARY ARTERY DISEASE. DURING PREPARATION, THE ROTAPRO PLATFORMED SUCCESSFULLY AT 160,000 ROTATIONS PER MINUTE (RPM) OUTSIDE THE BODY. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BODY, AND ONE ABLATION RUN WAS SUCCESSFULLY PERFORMED. DURING THE SECOND ABLATION RUN, THE SPEED INCREASED FROM 160,000 RPM TO 200,000 RPM. A WEIRD NOISE WAS HEARD, AND IT WAS AUDIBLY NOTED THAT THE SPEED SEEMED TO INCREASE AS WELL. AN ATTEMPT WAS MADE TO REDUCE THE ROTATION SPEED BY TURNING THE KNOB, BUT THERE WAS NO RESPONSE. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED BY PLACING A SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11381326 ↗MalfunctionFeb 18, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THE CONSOLE DISPLAYED INACCURATE AND UNSTABLE ROTATION SPEEDS. A ROTAPRO CONSOLE WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. DURING ABLATION INSIDE THE PATIENT, THE CONSOLE SHOWED RANDOM AND FAULTY ROTATION SPEEDS. THE DISPLAYED SPEEDS KEPT JUMPING ABOVE AND BELOW THE SET SPEED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345087 ↗MalfunctionFeb 18, 2021Output Problem; Output Problem
IT WAS REPORTED THAT THE CONSOLE DISPLAYED INACCURATE AND UNSTABLE ROTATION SPEEDS. A ROTAPRO CONSOLE WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. DURING ABLATION INSIDE THE PATIENT, THE CONSOLE SHOWED RANDOM AND FAULTY ROTATION SPEEDS. THE DISPLAYED SPEEDS KEPT JUMPING ABOVE AND BELOW THE SET SPEED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345069 ↗MalfunctionDec 4, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED/RESCHEDULED POST-SEDATION. A ROTAPRO CONSOLE WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. WHILE TESTING THE DEVICE OUTSIDE THE BODY, THE ROTATION SPEED WAS INCONSISTENT. THERE WAS NO EVIDENCE OF PHYSICAL DAMAGE TO THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10949331 ↗MalfunctionDec 2, 2020Unstable; Unstable
IT WAS REPORTED THAT ROTATION SPEED WAS ERRATIC. A ROTAPRO CONSOLE WAS SELECTED FOR AN ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, THE ROTATION SPEED FLUCTUATED AND RPMS COULD NOT BE MAINTAINED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10935745 ↗
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, ClassifiedROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Z-0915-2022 · Mar 8, 2022 · Open, ClassifiedROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
- Z-0211-2016 · Oct 9, 2015 · TerminatedRotaWire 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 · TerminatedRotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.