Visions PV .035 Digital IVUS Catheter 88901Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00845225002329), received between Jul 20, 2018 and Aug 26, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 13, 2022Class IIIOpen, Classified

   Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

   Z-1301-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453242 ↗
• MalfunctionMar 4, 2026No Device Output

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN AN EMERGENCY THERAPEUTIC PERIPHERAL PROCEDURE. DURING USE, THE CATHETER WAS RECOGNIZED BY THE IVUS SYSTEM BUT IMMEDIATELY DISCONNECTED. THE SYSTEM WAS RESTARTED TWICE; HOWEVER, THE PROBLEM REMAINED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED DURING AN EMERGENT PROCEDURE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507767 ↗
• MalfunctionFeb 26, 2026

  IVUS CATHETER .035 HAD A CONNECTION ISSUE, ON THE SCREEN A "DEFECT" ERROR CAME UP. CATHETER WAS WORKING CORRECTLY AT THE BEGINNING, BUT AFTER SOME TIME DEFECT ERROR CAME UP. CATHETER WAS REPLACED WITH NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 24454390 ↗
• MalfunctionDec 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING PULLBACK, THE CATHETER GOT STUCK ON THE GUIDEWIRE; THEREFORE, REMOVED TOGETHER AS A SYSTEM. A VENOGRAM WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785031 ↗
• MalfunctionDec 5, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A PROCEDURE. DURING USE, THE CATHETER DID NOT FUNCTION AS EXPECTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THE DEVICE WAS BEING USED IN AN EMERGENT PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE IT IS UNKNOWN IF THE FAILURE OCCURRED DURING AN EMERGENT PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733460 ↗
• MalfunctionNov 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED FOR A DIAGNOSTIC ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. DURING ADVANCEMENT, THE CATHETER GOT STUCK ON THE NON-PHILIPS GUIDEWIRE, MAKING IT IMPOSSIBLE TO PUSH OR RETRACT; THEREFORE, REMOVED TOGETHER AS A SYSTEM. A NEW VISIONS CATHETER AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND A NON-PHILIPS GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624743 ↗
• MalfunctionDec 13, 2024Poor Quality Image; Poor Quality Image

  THE INITIAL MDR WAS REPORTED FOR A POOR IMAGE THAT THE PATIENT WOULD BE BROUGHT BACK FOR IVUS IMAGING. HOWEVER, BASED ON THE DEVICE EVALUATION, THIS IS NO LONGER REPORTABLE SINCE THE CATHETER PRODUCED AND MAINTAINED A CLEAR IMAGE. THE CATHETER PERFORMED AS INTENDED; THEREFORE, THERE IS NO POTENTIAL FOR HARM FOR DELAY OF TREATMENT WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931460 ↗
• InjuryNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL ILIAC VESSEL. DURING ADVANCEMENT TO THE LESION, APPROXIMATELY 6 MM OF THE DISTAL TIP SEPARATED INSIDE THE INTRODUCER SHEATH. THE SEPARATED PORTION WAS SUCTIONED SUCCESSFULLY USING A SYRINGE. THE PROCEDURE WAS COMPLETED WITH A NEW VISIONS CATHETER. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164791 ↗
• InjuryAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED PROXIMAL ILIAC VESSEL. PRIOR TO USE OF THE VISIONS CATHETER, A BALLOON ANGIOPLASTY, THEN STENTING, FOLLOWED BY A POST BALLOON ANGIOPLASTY WERE PERFORMED. AFTER, THE VISIONS CATHETER WAS USED AND DURING REMOVAL, IT GOT CAUGHT IN THE PATIENT ANATOMY AND THE DISTAL TIP SEPARATED. THE SEPARATED PORTION WAS REMOVED WITH A SNARE. ANGIOGRAM CONFIRMED NO PIECE WAS RETAINED IN THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED WITH NO INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION, REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546229 ↗
• MalfunctionApr 20, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT VISIONS PV .035 CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING ADVANCEMENT TO THE LESION, THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM; TRIED RECONNECTING BUT WAS UNSUCCESSFUL. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, A PORTION OF THE KAPTON WAS LIFTED AT THE PROXIMAL FILLET, RESULTING IN A SHARP EDGE OF NON-MALLEABLE MATERIAL. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782066 ↗
• MalfunctionApr 9, 2021Material Separation; Material Separation

  THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A TIP SEPARATION HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646205 ↗
• MalfunctionJan 15, 2019No Display/Image

  WHILE USING THE IVUS CATHETER, WHEN INTRODUCING THE CATHETER INTO THE SHEATH, A MALFUNCTION OCCURRED AND LOST IMAGING; IT WENT BLACK. HAD TO THEN OPEN ANOTHER PACKAGE AND USE A NEW CATHETER. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8248242 ↗
• MalfunctionNov 28, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE THE IMAGE WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND OF THE SAME MAKE AND MODEL. VISUAL, MICROSCOPIC INSPECTION, AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE PIM CONNECTOR WAS SEPARATED AND NOT RETURNED WITH THE DEVICE. ADDITIONALLY, THE TIP WAS DEFORMED AND THE DEVICE WAS MISSING SMALL PORTIONS OF ADHESIVE. THE PROBABLE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED DUE TO THE PIM CONNECTOR BEING SEPARATED AND NOT RETURNED WITH THE DEVICE. 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, 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 8113899 ↗
• MalfunctionNov 20, 2018Failure to Advance

  ENDOGRAFT ILIAC STENT PLACEMENT. VOLCANO CATHETER WAS USED. THE WIRE DID NOT GO THROUGH IT. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED WITH THE VOLCANO CATHETER. THIS IS ONE OF 3 HYBRID EVENTS REGARDING , REFERENCE # 88901. WE SEARCHED THE INTERNET AND FOUND A 'MEDICAL DEVICE ADVISORY NOTICE' FOR THIS ITEM DATED 10/13/2018. NO KNOWN FORMAL NOTIFICATION BY THE COMPANY HAS BEEN RECEIVED. ACCORDING TO THE UDI# (B)(4) IS A BATCH NUMBER THAT IS INCLUDED IN THE ADVISORY NOTICE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089818 ↗
• MalfunctionNov 20, 2018Failure to Advance

  IVUS CATHETER WAS USED. THE WIRE NEVER ENTERED PATIENT'S BODY. THE WIRE DID NOT PASS THROUGH THE IVUS; GUIDEWIRE WOULD NOT PASS THROUGH CATHETER. NO PATIENT HARM. THIS IS ONE OF 3 HYBRID EVENTS REGARDING , REFERENCE # 88901. WE SEARCHED THE INTERNET AND FOUND A 'MEDICAL DEVICE ADVISORY NOTICE' FOR THIS ITEM DATED 10/13/2018. NO KNOWN FORMAL NOTIFICATION BY THE COMPANY HAS BEEN RECEIVED. ACCORDING TO THE UDI# (B)(4) IS A BATCH NUMBER THAT IS INCLUDED IN THE ADVISORY NOTICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089739 ↗
• MalfunctionSep 14, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THERE WAS NO IMAGE AND THE SCREEN WAS BLACK WHEN THE MANUFACTURER'S DEVICE WAS IN THE PATIENT'S BODY. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. IMAGE AND FUNCTIONAL TESTING COULD NOT BE CONDUCTED AS THE PIM CONNECTOR WAS CUT AND NOT RETURNED WITH THE DEVICE. ADDITIONALLY, THERE WERE SCRATCHES ALONG THE FILLET AND A SMALL PORTION OF THE ADHESIVE WAS MISSING. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE PROBABLE CAUSE OF THE REPORTED FAILURE (NO IMAGE) COULD NOT BE DETERMINED. THE PROBABLE CAUSE OF THE OBSERVED MISSING ADHESIVE COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE A PORTION OF THE DEVICE WAS MISSING AND IT COULD NOT BE C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7879358 ↗
• MalfunctionJul 21, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, THE MANUFACTURER'S DEVICE WAS PLUGGED IN AND A BLACK SCREEN WAS DISPLAYED. NO IMAGE WAS DISPLAYED. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE MANUFACTURERS DEVICE WAS BEING USED FOR PERIPHERAL DIAGNOSTIC IMAGING. VISUAL AND MICROSCOPIC INSPECTION AND AN IMAGE TEST WERE PERFORMED ON THE RETURNED DEVICE. THE DEVICE WAS CONNECTED TO THE LAB IMAGING SYSTEM AND PRODUCED A PROPER IMAGE. NO ERROR OCCURRED UPON MANIPULATION OF THE SCANNER BODY. BOTH PROXIMAL AND DISTAL FILLETS HAD SCRATCHES. ROTATION FORCE WAS APPLIED ON THE DISTAL TIP. TWISTING BETWEEN THE SCANNER BODY AND THE DISTAL TIP WAS OBSERVED WITHIN THE ADHESIVE ON THE DISTAL FILLET. THERE WERE INDICATIONS OF MISSING FILLET MATERIAL ON BOTH THE DISTAL AND PROXIMAL ENDS OF THE SCANNER BODY. THE DEVICE PRODUCED AND MAINTAINED A CLEAR, PROPER IMAGE WITH THE IMAGING SYSTEM. AS A RESULT, THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS MISSING ADHESIVE AT BOTH THE DISTAL AND PROXIMAL FILLETS. THE PROBABLE CAUSE OF THE MISSING ADHESIVE IS DAMAGE IN USE, LIKELY SCRATCHED AWAY AS IT PASSED THROUGH A TIGHT OCCLUSION, AS EVIDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7708982 ↗
• MalfunctionJul 20, 2018Image Display Error/Artifact

  DURING THE CASE, THE VOLCANO IVUS CATHETER WORKED AND HAD IMAGES. IT THEN STOPPED WORKING, AND HAD NO IMAGES DURING USE. THE CASE WAS AT A POINT WHERE THE SURGEON WAS FINISHED WITH THE CATHETER. THERE WAS DRIED BLOOD NOTED WHERE THE CATHETER IS INSERTED INTO THE GENERATOR. THE GENERATOR WAS TAKEN TO BIOMED FOR ANALYSIS.

  Patient problems: Blood Loss

  MAUDE report 7705873 ↗