Visions PV .014P RX Digital IVUS Catheter 85910PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845225002428), received between Jan 20, 2017 and Sep 28, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PERIPHERAL PROCEDURE, OUTSIDE BODY, AFTER USE, DURING INSERTION IN THE ARTERY, THE WIRE DID NOT GO THROUGH THE "WIRE EXIT PORT." THERE IS NO PATIENT INJURY. THE RETURNED DEVICE WAS INSPECTED AND DAMAGE WAS OBSERVED. A PORTION OF ADHESIVE WAS MISSING ON THE PROXIMAL FILLET AROUND THE SCANNER GROUND PAD. ADDITIONALLY, A DEEP SCRATCH WAS PRESENT ON THE DISTAL FILLET OF THE DISTAL TIP AND SOME ADHESIVE WAS ALSO MISSING FROM THAT REGION. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE ADHESIVE WAS MISSING FROM THE DEVICE AND IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7917336 ↗
• MalfunctionAug 27, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THE IMAGE DISAPPEARED ON THE MANUFACTURER'S DEVICE. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENTS. VISUAL, MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE ADHESIVE AT THE DISTAL FILLET WAS LIFTED AND A PORTION OF THE ADHESIVE WAS MISSING. THE DEVICE WAS RECOGNIZED BY THE SYSTEM AND PRODUCED A PROPER IMAGE DURING IMAGE TESTING. NO ERROR WAS OBSERVED WITH MANIPULATION NEAR THE SCANNER BODY. THE PROBABLE CAUSE OF THE REPORTED "IMAGE DISAPPEARED" FAILURE IS AN INSUFFICIENT AMOUNT OF ADHESIVE THAT LED TO FLUID INGRESS AND ELECTRICAL DISCONTINUITY AT THE SCANNER BODY AS A RESULT. THE PROBABLE CAUSE OF THE OBSERVED PORTION OF MISSING ADHESIVE COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION, AND THEREFORE IT COULD NOT BE DETERMINED WHEN THE CAUSE OF THE FAILURE OCCURRED. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVIC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7815540 ↗
• InjuryJul 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THE MANUFACTURER'S DEVICE WAS STUCK IN THE PATIENT'S BODY. THE USER WAS UNABLE TO PULL OUT THE MANUFACTURER'S DEVICE AND ULTIMATELY SURGICAL REMOVAL WAS DONE. PATIENT RECOVERED AND WAS RELEASED. THIS MDR IS BEING SUBMITTED BECAUSE MEDICAL AND SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER DEVICE.

  Patient problems: Injury

  MAUDE report 7737880 ↗
• MalfunctionMay 2, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED THERAPEUTIC PERIPHERAL PROCEDURE THE IMAGE DISAPPEARED FROM THE MANUFACTURER'S CATHETER DEVICE WHILE PASSING THE LEGION. NO RESISTANCE WAS ENCOUNTERED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DEVICE. THERE WAS NO PATIENT INJURY, NO ADVERSE EVENT, AND NO ADDITIONAL INTERVENTION WAS REQUIRED TO PREVENT INJURY. A SECOND DEVICE OF SAME MAKE AND MODEL WAS USED TO COMPLETE THE PROCEDURE. A VISUAL AND MICROSCOPIC INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. SCRATCHES WERE OBSERVED ON THE PROXIMAL FILLET, DISTAL FILLET AND DYE FACE. THE ADHESIVE OF THE PROXIMAL FILLET WAS DAMAGED, AND SOME OF THE ADHESIVE APPEARED TO BE MISSING. SOME PORTIONS OF THE ADHESIVE OF THE PROXIMAL FILLET WERE ALSO LIFTED. SANGUINEOUS RESIDUE WAS OBSERVED UNDER THE ADHESIVE OF THE PROXIMAL FILLET. THE DISTAL TIP WAS DEFORMED. THE DEVICE WAS CONNECTED TO THE LAB'S SYSTEM FOR AN IMAGE TEST. THE DEVICE WAS RECOGNIZED, BUT THE GENERATED IMAGE WAS INCOMPLETE, AND THEN THE IMAGE DISAPPEARED AND THE SYSTEM DISPLAYED THE "CATHETER FAULT DETECTED" ERROR MESSAGE. THE OBSERVED SANGUINEOUS RESIDUE UNDERNEATH THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481659 ↗
• MalfunctionFeb 10, 2017Material Separation; Physical Resistance; Material Separation; Physical Resistance

  IT WAS REPORTED THE PHYSICIAN GAINED ACCESS ON THE RIGHT SIDE USING A .014 JOURNEY WIRE. THEY WERE ABLE TO ADVANCE THE CATHETER OVER THE WIRE, AND OVER THE BIFURCATION. THEY RECORDED THE RUN GOING DOWN [TO THE LESION] AND HAD NO DIFFICULTIES. WHEN RECORDING THE RUN BACK [PULL BACK] THEY FELT RESISTANCE AND HAD TROUBLE REMOVING THE CATHETER. THE PHYSICIAN WAS UNABLE TO MOVE BACK OVER THE WIRE. WHEN REMOVING CATHETER AND WIRE, UPON REACHING THE SHEATH, THE CATHETER WOULD NOT ADVANCE. THE PHYSICIAN WAS UNABLE TO RE-ENTER THE SHEATH FOR REMOVAL. THE CATHETER AND WIRE WERE REMOVED AS A SYSTEM. THE CATHETER BROKE INTO TWO PIECES. THE PHYSICIAN HAD DIFFICULTY RETRIEVING THE PROXIMAL PORTION OUT OF THE VESSEL, HOWEVER ALL PIECES WERE ACCOUNT FOR UPON REMOVAL. IVUS WAS DISCONTINUED FOR THE REMAINDER OF THE CASE, BUT THEY WERE ABLE TO ACCESS THE LEFT SIDE AND COMPLETED THE CASE BY STENTING. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THE VESSEL WAS DESCRIBED AS: STANDARD SFA LESION, 50%-70% OCCLUDED (SPECULATED), NO TORTUOSITY. OTHER DEVICES IN USE: TERUMO 6FX45CM SHEATH, BOSTON SCIENTIFIC JOURNEY WIRE (260CM).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6324462 ↗
• MalfunctionJan 20, 2017Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE CUSTOMER REPORTED DURING A PERIPHERAL PROCEDURE, A LESION BELOW THE KNEE WAS INFLATED BY A BALLOON CATHETER. THE CATHETER WAS DELIVERED TO DISTAL OF THE LESION. RESISTANCE WAS MET DURING PULLBACK INSIDE THE BODY AND THE CATHETER COULD NOT MOVE WITH THE GUIDEWIRE (GW). THE GW WAS HELD BY HAND AND THE CATHETER WAS REMOVED BY ITSELF. UPON REMOVAL, THE DISTAL TIP OF THE CATHETER WAS MISSING. WHEN THE GW WAS REMOVED, THE MISSING DISTAL TIP OF THE CATHETER WAS ON THE GW. ANOTHER SAME PRODUCT AND GW WERE USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS INSPECTED DURING PREP AND NO DAMAGE WAS OBSERVED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED OR PERFORMED. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENTS. PATIENT WAS DISCHARGED AS EXPECTED AND PATIENT'S CONDITION WAS NOTED AS "STABLE." THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6268765 ↗