Rotablator™ Rotational Atherectomy System Console Kit H802220200391Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729353300), received between Aug 9, 2017 and Jul 1, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Output Problem” (9 reports).

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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024No Display/Image; Defective Device; No Display/Image; Defective Device

  IT WAS REPORTED THAT THE CONSOLE SCREEN FAILED TO DISPLAY THE ROTATIONAL SPEED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SPEED READING WAS NOT DISPLAYED ON THE SCREEN, EVEN WHEN THE FOOT PEDAL WAS SWITCHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643244 ↗
• MalfunctionMar 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DISPLAY FAILURE OCCURRED. A ROTABLATOR CONSOLE KIT ASSY WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LED DISPLAY WAS BLANK AND NOT WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534911 ↗
• MalfunctionFeb 28, 2023Unstable; Material Integrity Problem; Unstable; Material Integrity Problem

  IT WAS REPORTED THAT THE SPEED WAS EXCEEDED THE SET ROTATIONAL SPEED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A CE ROTABLATOR WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED COULD NOT BE ADJUSTED PRECISELY BY TURBINE PRESSURE CONTROL KNOB. IT SEEMS THAT THE KNOB WAS LOOSE. CONSEQUENTLY, IT WAS NOTED THAT THE OBSERVED MAXIMUM SPEED WAS 200,000RPM VS SET ROTATIONAL SPEED OF 160,000RPM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455815 ↗
• MalfunctionApr 1, 2022Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS TOO HIGH. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTABLATOR IS NOT FUNCTIONING PROPERLY. WHEN IT WAS CONNECTED TO THE GAS AND SET TO THE OPTIMAL RANGE, THE SPEED WAS TOO HIGH AND IS UNABLE TO BE TURNED BACK DOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979751 ↗
• MalfunctionJun 7, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT ROTA CONSOLE CAN NOT DISPLAY THE RPM NUMBER. VASCULAR ACCESS WAS OBTAINED VIA BRACHIAL ARTERY. THE 90% STENOSED, 28MM X 2.5MM, ECCENTRIC, IN-STENT RESTENOSIS TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT CIRCUMFLEX ARTERY. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS FOUND THAT THE ROTA CONSOLE DID NOT DISPLAY RPM NUMBER. THE CONSOLE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947716 ↗
• MalfunctionApr 27, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE RPM SPEED IS MISREADING. IT WAS NOTED THAT THE RPM OF A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE WAS NOT FUNCTIONING PROPERLY AND A RPM SPEED WAS MISREADING. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735657 ↗
• MalfunctionDec 23, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CONSOLE DISPLAY SCREEN WAS DEFECTIVE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE REVOLUTIONS PER MINUTE (RPM) READOUT SCREEN WAS REPORTED TO BE DEFECTIVE. THE PROCEDURE WAS STOPPED. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT SINCE THE BURR WAS NOT INTRODUCED TO THE ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11065554 ↗
• MalfunctionDec 10, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE ROTATION WAS UNABLE TO STOP. A CE ROTABLATOR WAS SELECTED FOR USE. THE FOOT PEDAL WAS DAMAGED. ROTATION WOULD NOT STOP FOR A WHILE EVEN IF THE FOOT WAS RELEASED FROM THE FOOT PEDAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10983895 ↗
• MalfunctionSep 3, 2020Unstable; Output Problem; Unstable; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE IN A ROTATIONAL ATHERECTOMY PROCEDURE. DURING THE PROCEDURE, THE ROTALINK PLUS WAS CONNECTED AND THE ROTATION SPEED WAS ADJUSTED. HOWEVER, THERE WAS NO RESPONSE FROM THE EQUIPMENT TO THE SPEED ADJUSTMENT OF THE CONTROL KNOB LEADING TO HIGH REVOLUTIONS WITHOUT CONTROL. THE PROCEDURE WAS UNSUCCESSFUL AND WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE OPERATING SPEED IS SET ACCORDING TO THE SIZE OF THE BURR; A SET SPEED DOES NOT COME BY DEFAULT. THE MAXIMUM SPEED REACHED IS 260 RATE PER MINUTE (RPM). THE OPERATING SPEED COULD NOT BE ESTABLISHED AS THE EQUIPMENT DID NOT RESPOND TO THE RPM SETTING. TO COMPLETE THE PROCEDURE, HIGH PRESSURE BALLOONS WERE USED TO MODIFY THE PLATE AND IMPLANT THE STENT. THE PATIENT IS STABLE AND ON MEDICAL DISCHARGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489280 ↗
• MalfunctionNov 21, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE EXCEEDED THE SET SPEED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE AND WAS SET TO 150 RPM. IT WAS REPORTED THAT THE CONSOLE SPEED EXCEEDED TO 190 RPM. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354800 ↗
• MalfunctionNov 7, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE CONSOLE WAS NOT DISPLAYING THE ROTATIONAL SPEED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISPLAY DID NOT SHOW THE REVOLUTIONS. THE USAGE OF THE EQUIPMENT WAS STOPPED AND THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291647 ↗
• MalfunctionNov 7, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE RPM DISPLAY WAS FAULTY. A ROTABLATOR CONSOLE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTATIONAL SPIN DISPLAY ON THE ROTABLATOR CONSOLE WAS FAULTY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291540 ↗
• MalfunctionJun 7, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. THE ROTATIONAL SPEED OF THE DEVICE KEPT INCREASING AND DECREASING AND WAS UNSTABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8678625 ↗
• MalfunctionMay 16, 2019Output Problem; Output Problem

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON 06MAY2019. IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE ROTATION SPEED COULD NOT BE CONTROLLED AND WAS UNSTABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8615614 ↗
• MalfunctionMar 22, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE RPM OF THE DEVICE WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING PREPARATION, THE RPM OF THE DEVICE DID NOT INCREASE MORE THAN 180,000 RPM. HOWEVER, IT SUDDENLY INCREASED UP TO 200,000 RPM INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444098 ↗
• MalfunctionMar 21, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE RPM OF THE DEVICE WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING PREPARATION, THE RPM OF THE DEVICE DID NOT INCREASE MORE THAN 180,000 RPM. HOWEVER, IT SUDDENLY INCREASED UP TO 200,000 RPM INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441638 ↗
• MalfunctionMar 19, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATIONAL SPEED WAS SET AT 180,000RPM; HOWEVER, IT WAS NOTED THAT THE SPEED REACHED TO 200,000RPM. FURTHERMORE, THE ROTATION SPEED WAS NOTED TO BE UNSTABLE. THERE WERE LARGE DIFFERENCE BETWEEN THE ROTATIONAL SPEED SET OUTSIDE THE PATIENT AND THE ROTATIONAL SPEED AT PLATFORM OR AT PROXIMAL OF THE LESION. THE OPERATOR COULD NOT ADJUST THE ROTATIONAL SPEED AS NEEDED AS THE TURBINE PRESSURE CONTROL KNOB IS DIFFICULT AND TIME LOG WOULD OCCUR IN ADJUSTING THE ROTATION SPEED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433394 ↗
• MalfunctionDec 10, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE DEVICE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS REPORTED THAT ROTATIONAL SPEED WAS NOT STABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8147218 ↗
• MalfunctionNov 8, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE ROTATIONAL SPEED WAS UNSTABLE. A ROTABLATOR CONSOLE KIT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE ROTATIONAL SPEED WAS UNSTABLE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053067 ↗
• MalfunctionNov 5, 2018No Display/Image; Activation Problem; No Display/Image; Activation Problem

  IT WAS REPORTED THAT THE CONSOLE RPM DISPLAYED INTERMITTENTLY. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE ROTABLATOR CONSOLE FAILED TO GO INTO DYNAGLIDE MODE AND THE RPM DISPLAY WORKED INTERMITTENTLY. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8038095 ↗
• MalfunctionNov 5, 2018No Display/Image; No Display/Image

  IT WAS REPORTED THAT A DISPLAY ISSUE OCCURRED. A ROTABLATOR CONSOLE WAS SELECTED FOR USE. UPON TESTING, OUTSIDE PATIENT'S BODY, IT WAS NOTED THAT ROTATIONAL SPEED WOULD NOT DISPLAY AT A LOW OR HIGH SPEED. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037522 ↗
• MalfunctionOct 30, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS NOTED THAT THE ROTATION SPEED WAS UNSTABLE AND THE ADJUSTMENT OF THE KNOB DOES NOT WORK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021146 ↗
• MalfunctionOct 8, 2018Unstable; Unstable

  IT WAS REPORTED THAT CONSOLE HAD ERRATIC SPEED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RPM NUMBERS WERE FLUCTUATING WITHOUT THE DIAL BEING TOUCHED AT ALL. THE NUMBERS WILL GO FROM 120RPM TO 220RPM TO 150RPM TO 120RPM. THE PROCEDURE WAS BEING ABORTED AND NOT RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943475 ↗
• MalfunctionOct 2, 2018Output above Specifications; Output above Specifications

  IT WAS REPORTED THAT THE SPEED KEEP INCREASING. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SPEED KEEP INCREASING AFTER THE ROTATIONAL SPEED WAS SET. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7927799 ↗
• MalfunctionSep 18, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT WAS SELECTED FOR USE. IT WAS NOTED THAT IT WAS DIFFICULT TO ADJUST THE ROTATION SPEED IN THE CONSOLE. NO PATIENT INVOLVEMENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886153 ↗