Revolution Rotational Imaging Catheter 89000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00184360000358), received between Mar 3, 2017 and May 28, 2020 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2020Material Fragmentation; Material Fragmentation

  IT WAS INITIALLY REPORTED DURING A DIAGNOSTIC CORONARY PROCEDURE WHEN REMOVING THE MANUFACTURER¿S CATHETER DEVICE THE TIP WAS DISCONNECTED AND REMAINS IN PATIENT. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A PORTION OF THE MANUFACTURES DEVICE IS REPORTED TO REMAIN IN THE PATIENT POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10098382 ↗
• InjuryJan 17, 2020Material Fragmentation; Material Fragmentation

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #3 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN G4, THE DATE RECEIVED BY MANUFACTURER (BECOMES AWARE DATE).

  Patient problems: Foreign Body In Patient

  MAUDE report 9602732 ↗
• InjuryJul 10, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING AN URGENT UNPLANNED THERAPEUTIC PCI [PERCUTANEOUS CORONARY INTERVENTION], THE MANUFACTURER'S CATHETER STUCK AT HIGH LATERAL (#12) AND COULD NOT BE RETRIEVED DURING PULLBACK. IN ORDER TO RELEASE THE STUCK, THE PROXIMAL SHAFT WAS CUT AND CORE WIRE WAS REMOVED AND GW [GUIDEWIRE] INSERTED, BUT COULD NOT BE REMOVED. ANOTHER FEMORAL ARTERY WAS PUNCTURED AND ATTEMPTED TO INSERT THE GW TO RELEASE THE STUCK BUT GW COULD NOT BE PLACED BESIDE THE CATHETER. ALSO, THE PHYSICIAN ADVANCED BALLOON CATHETER TO LAD AND ANCHORED, THEN ATTEMPTED TO RETRIEVE BUT COULD NOT. PATIENT HEMODYNAMICS WORSENED AND DETERMINED TO USE PCPS [PERCUTANEOUS CARDIOPULMONARY SUPPORT] AS SOON AS POSSIBLE. THE PATIENT WAS TRANSFERRED TO UNIVERSITY HOSPITAL AND HAD OPEN-HEART SURGERY. THE CATHETER COULD BE RETRIEVED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE MANUFACTURER'S DEVICE.

  Patient problems: Cardiopulmonary Arrest; Foreign Body In Patient

  MAUDE report 8779090 ↗
• MalfunctionMar 15, 2019Material Separation; Material Separation

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO ADVISE PERTINENT DEVICE ANALYSIS FINDINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424577 ↗
• InjuryJun 22, 2018Material Separation; Material Separation

  THIS CASE WAS INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, THE CATHETER BROKE INTO HALF DURING REMOVAL. THE BROKEN HALF OF THE CATHETER REMAINED IN THE GUIDER AND BOTH WERE REMOVED. NO TROUBLESHOOTING WAS PERFORMED. NOTHING WAS LEFT IN THE PATIENT. THIS EVENT IS BEING REPORTED BECAUSE THE DEVICE WAS REMOVED AS A SYSTEM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7630664 ↗
• MalfunctionJan 12, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THE CATHETER WAS USED FOR PCI (PERCUTANEOUS CORONARY INTERVENTION). AFTER TWO (2) STENTS WERE PLACED IN LAD #6 AND #7, THE THIRD IVUS WAS DONE. DURING REMOVAL AND WHEN ABOUT 90% OF THE CATHETER SHAFT WAS OUTSIDE THE GUIDE CATHETER (GC), THE DISTAL SHAFT WAS EASILY SEPARATED INTO 2 PIECES AT THE USER'S HAND AND THE TRANSDUCER WAS EXPOSED FROM THE DISTAL SHAFT. NO DAMAGE WAS OBSERVED TO THE DEVICE DURING PREP. CUSTOMER NOTED THE DEVICE WAS NOT STUCK AT ANY POINT, NOR WAS RESISTANCE FELT AT ANY POINT. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT'S BODY. THERE IS NO PATIENT INJURY, NO ADVERSE EVENTS, AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. PATIENT'S TREATMENT WAS COMPLETED BY THE PROCEDURE AND THE PATIENT WAS DISCHARGED AS EXPECTED IN STABLE CONDITION. VESSEL: LAD #S 6 & 7, CALCIFIED LESION. THE DEVICE WAS RETURNED ON 01-03-2018 AND DEVICE ANALYSIS IS IN PROGRESS. THE INSTRUCTIONS FOR USE (IFU) WARNS TO EXERCISE CARE WHEN ADVANCING THE CATHETER DISTAL TO A DEPLOYED STENT. THE SHORT MONORAIL SEGMENT CAN RESULT IN EXPOSURE OF THE GU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7188057 ↗
• InjuryDec 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED DURING A CORONARY THERAPEUTIC PROCEDURE THAT DURING INSERTION PRIOR TO CROSS[ING] THE SEVERELY CALCIFIED LESION INSIDE THE BODY THE CATHETER WAS TRAPPED AND COULD NOT BE MOVED BACK. THE INNER CATHETER (DRIVE CABLE, ETC.) WAS REMOVED FROM THE CONNECTOR AND A GW (GUIDE WIRE) WAS INSERTED INTO THE OUTER CATHETER FROM THE CONNECTOR. THE GW AND THE CATHETER WERE REMOVED TOGETHER AS A SYSTEM FROM THE BODY. THERE WAS NO PATIENT INJURY. VESSEL: #7 / CALCIFICATION: SEVERE. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089479 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED DURING INSERTION PRIOR TO CROSS THE LESION INSIDE THE BODY THE IMAGE DISAPPEARED. THE CATHETER AND THE PIMR WERE RECONNECTED TO THE PIMR AND THE SYSTEM, AND THE SYSTEM WAS REBOOTED BUT THE PROBLEM WAS NOT SOLVED. THE PATIENT CONDITION WAS SUDDENLY CHANGED AND THE PROCEDURE WAS ABORTED. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION AS BY REPORT THE PATIENT'S CONDITION CHANGED SUDDENLY AND PROCEDURE WAS ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6695636 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED FOR A THERAPEUTIC PROCEDURE, PRIOR TO THE PROCEDURE, THE USER PLUGGED IN MANUFACTURER'S CATHETER DEVICE AND RECEIVED NO IMAGE. A SECOND CATHETER DEVICE OF SAME WAS PULLED AND HAD THE SAME ISSUE NO IMAGE (CASE #(B)(4)). AT THIS POINT THE DOCTOR ABORTED THE CASE. THERE WAS NO HARM TO PATIENT. THE RETURNED DEVICE WAS RECEIVED DAMAGED. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE PROXIMAL SHAFT OF THE RETURNED DEVICE WAS SEPARATED AT 655MM DISTAL TO THE DISTAL TELESCOPE STRAIN RELIEF. THE SHAFT WAS SLIGHTLY FLATTENED AT THE BREAK, INDICATING THE SHAFT WAS KINKED PRIOR TO THE SEPARATION. THE EXPOSED DRIVE CABLE WAS ALSO KINKED. A CAPACITANCE TEST WAS PERFORMED AND THE DEVICE FAILED. THE CAPACITANCE WAS UNSTABLE TO MEASURE. NO ADDITIONAL TESTING BEYOND THE CAPACITANCE TEST WAS ABLE TO BE PERFORMED DUE TO THE KINK AND SHAFT SEPARATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. DEVICE MANIPULATION, IMPACT AND APPLIED PRESSURE DURING USE CAN AFFECT THE INTEGRITY OF THE DEVICE. UNFORTUNATELY, WE COULD NOT CONCLUSIVELY DETERMINE WHEN OR HOW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664942 ↗
• MalfunctionJun 2, 2017Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PERIPHERAL PROCEDURE THE CATHETER DEVICE WAS USED FOR EVT (ENDOVASCULAR THERAPY. DURING PULLBACK INSIDE THE BODY THE IMAGE DISAPPEARED. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS FELT AT ANY TIME. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT'S BODY. TREATMENT WAS COMPLETED BY THE PROCEDURE WITH NO ADVERSE EVENTS OR ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY. PATIENT WAS DISCHARGED AS EXPECTED IN STABLE CONDITION. THE DEVICE WAS RETURNED AND EVALUATED IN ACCORDANCE WITH PHILIPS VOLCANO POLICY. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE CATHETER WAS RECEIVED WITH A SHAFT SEPARATION AT 338MM DISTAL TO THE DISTAL TELESCOPE STRAIN RELIEF. SOME BLACK RESIDUE WAS OBSERVED NEAR THE DISTAL END BREAK OF THE SHAFT. NO DAMAGE WAS OBSERVED ON THE EXPOSED DRIVE CABLE. A CAPACITANCE TEST WAS PERFORMED AND THE DEVICE PASSED WITH A VALUE WITHIN THE EXPECTED RANGE. THIS DEMONSTRATES THAT THE COAXIAL CABLE WAS INTACT BETWEEN THE CONNECTOR AND THE TRANSDUCER, AND THE DEVICE SHO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6609859 ↗
• InjuryApr 28, 2017Difficult to Remove; Difficult to Remove

  THIS EVENT IS BEING REPORTED BECAUSE THE CATHETER AND GUIDE WIRE WERE REMOVED AS A SYSTEM DURING A CORONARY PROCEDURE. THIS MDR SUBMISSION IS FOR THE CATHETER. THE GUIDE WIRE IS SUBMITTED UNDER MDR 2939520-2017-00043. IT WAS REPORTED DURING A THERAPEUTIC PROCEDURE AFTER COMPLETING IFR WITH THE GUIDE WIRE, THE CATHETER DEVICE WAS INTRODUCED AND THE PHYSICIAN PROCEEDED TO TAKE IT DOWN THE WIRE. THE PHYSICIAN ENCOUNTERED DIFFICULTY STEERING DOWN THE VESSEL. THE PROCEDURE WENT FINE UNTIL THEY TRIED TO REMOVE THE CATHETER DEVICE. AT THIS POINT IT WAS SHOWING RESISTANCE AND THEY MOVED THE CATHETER FORWARD AND BACKWARD BUT THE WIRE WAS STILL ATTACHED TO THE CATHETER. THE PHYSICIAN THEN PROCEEDED TO REMOVE THE WIRE AND CATHETER AS A COMPLETED UNIT, AND AT THIS POINT THEY NOTICED THE WIRE WAS FRAYED AND PART OF IT CAME APART OUTSIDE THE BODY. ALL PIECES WERE ACCOUNTED FOR; THE POST-IMAGE OF THE VESSEL LOOKED FINE. NO HARM TO THE PATIENT. PATIENT WAS DISCHARGED AS EXPECTED. VESSEL: CORONARY. THE VESSEL WAS A BIT TORTUOUS MINIMAL CALCIUM WAS PRESENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6531055 ↗
• InjuryApr 26, 2017Material Separation; Material Separation

  IT WAS REPORTED THE CATHETER WAS USED FOR PCI (PERCUTANEOUS CORONARY INTERVENTION). DURING REMOVAL, THE PROXIMAL SHAFT SEPARATED AND THE DISTAL PART REMAINED INSIDE THE BODY. THE DISTAL PART WAS RETRIEVED WITH A SNARE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE GUIDEWIRE AND CATHETER WERE REMOVED AS A SYSTEM. NO DAMAGE WAS OBSERVED DURING PREP. THE CUSTOMER NOTED RESISTANCE WAS ENCOUNTERED. PATIENT'S TREATMENT WAS COMPLETED BY THE PROCEDURE. THERE WAS NO PATIENT INJURY. PATIENT'S CONDITION WAS NOTED AS "STABLE." VESSEL: LAD#6~#8, OCCLUSION: 90%, TORTUOUSNESS: SEVERE, CALCIFICATION: MODERATE, PLAQUE: MIXED THIS EVENT IS BEING REPORTED AS ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE A PORTION OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6524896 ↗
• InjuryMar 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING REMOVAL THE CATHETER GOT STUCK AT THE DISTAL PART OF A STENT AT RCA#2 INSIDE THE BODY. A GUIDELINER WAS USED TO HOLD THE CATHETER AND THEY WERE REMOVED TOGETHER AS A SYSTEM. TREATMENT WAS COMPLETED BY THE PROCEDURE. THERE WAS NO PATIENT INJURY. NO DAMAGE WAS OBSERVED DURING PREP. RESISTANCE WAS FELT IN THE BODY AND THE DEVICE STUCK ON THE STENT. ALL PORTIONS OF THE DEVICE APPEARED TO BE ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO FREE THE DEVICE FROM THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378174 ↗