Visions PV .035 Digital IVUS CatheterRecalls & reported problems across all models

We found 2 models of Visions PV .035 Digital IVUS Catheter by Philips Image Guided Therapy Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2018 and Aug 26, 2026 — classified as 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Visions PV .035 Digital IVUS Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 13, 2022Class IIIOpen, Classified

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

   Z-1302-2022 · Root cause: Process control · Recall details · FDA record ↗

2. 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 Visions PV .035 Digital IVUS Catheter problems

Visions PV .035 Digital IVUS Catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Visions PV .035 Digital IVUS Catheter 88901

  Catheter, Ultrasound, Intravascular
  1 recall18 reports
• Visions PV .035 Digital IVUS Catheter 81234

  Catheter, Ultrasound, Intravascular
  1 recall14 reports

Recent Visions PV .035 Digital IVUS Catheter adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. SOMETIME DURING THE PROCEDURE, THE CATHETER WAS BENT AND THE TIP WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THERE WAS NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996321 ↗
• 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 ↗
• MalfunctionApr 17, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A PERIPHERAL PROCEDURE TO VISUALIZE VENOUS COMPRESSION OF THE MID COMMON ILIAC VEINS. WHILE LOADING THE CATHETER ONTO A NON-PHILIPS GUIDEWIRE, THE CATHETER BECAME STUCK, AND BOTH WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER VISIONS CATHETER. 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 21859242 ↗
• MalfunctionMar 13, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT A VISIONS PV .035 CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE. DURING USE, THE CATHETER WAS NOT RECOGNIZED BY THE SYSTEM. THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED. NO PATIENT INJURY WAS REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600985 ↗
• 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 ↗
• MalfunctionMay 17, 2023Material Separation; Material Separation

  FROM INITIAL MDR SUBMITTED ON 10/12/2018 (MFR REPORT # 2939520-2018-00132): THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER''S POLICY. IT WAS REPORTED, DURING AN AFTER USE INSPECTION OF THE MANUFACTURER''S DIAGNOSTIC DEVICE, IT WAS OBSERVED THE DISTAL TIP GLUE WAS COMING OFF FROM THE TRANSDUCER. ADDITIONAL INFORMATION PROVIDED THE PROCEDURE WAS AN AV ACCESS VENOUS CASE. AFTER THE FIRST RUN THE PHYSICIAN OBSERVED THE TIP APPEARED AS THOUGH IT HAD DELAMINATED OR THAT GLUE HAD SEPARATED FROM THE DEVICE. THE TIP WAS NOT DEFORMED NOR SEPARATED FROM THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND OF THE SAME MAKE AND MODEL. 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 THERE IS A POTENTIAL FOR HARM IF MATERIAL IS MISSING FROM THE DEVICE. FROM SUPPLEMENTAL MDR SUBMITTED ON 12/26/2018 (MFR REPORT # 2939520-2108-00132): THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER''S POLICY. THIS FOLLOW-UP REPORT (# 1) IS BEING SUBMITTED TO REPORT DEVICE ANALYSIS OBSERVATIONS FOR MANUFACTURE''S DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945154 ↗
• InjuryMay 2, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PATIENT WAS UNDER SEDATION WITH MODERATE ANESTHESIA. THE VISIONS PV .035 CATHETER WAS FLUSHED AND CALIBRATED PRIOR TO LOADING OVER A GUIDEWIRE. UPON ADVANCING THE CATHETER INSIDE THE PATIENT, NO IMAGE WAS DISPLAYED ON THE MONITOR. THE PROCEDURE WAS ABORTED WITHOUT COMPLETING THE IVUS EVALUATION. THE PATIENT REQUIRES AN ADDITIONAL INVASIVE PROCEDURE TO COMPLETE THE EVALUATION AT A LATER DATE. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE PATIENT WAS UNDER SEDATION, AND UNABLE TO COMPLETE THE PROCEDURE. THIS RESULTED IN A DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857551 ↗
• InjuryMay 2, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PATIENT WAS UNDER SEDATION WITH MODERATE ANESTHESIA. THE VISIONS PV .035 CATHETER WAS FLUSHED AND CALIBRATED PRIOR TO LOADING OVER A GUIDEWIRE. UPON ADVANCING THE CATHETER INSIDE THE PATIENT, NO IMAGE WAS DISPLAYED ON THE MONITOR. THE PROCEDURE WAS ABORTED WITHOUT COMPLETING THE IVUS EVALUATION. THE PATIENT REQUIRES AN ADDITIONAL INVASIVE PROCEDURE TO COMPLETE THE EVALUATION AT A LATER DATE. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE PATIENT WAS UNDER SEDATION, AND UNABLE TO COMPLETE THE PROCEDURE. THIS RESULTED IN A DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857546 ↗

Other Philips Image Guided Therapy Corporation products

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