Visions PV .014P RX Digital IVUS CatheterRecalls & reported problems across all models

We found 2 models of Visions PV .014P RX Digital IVUS Catheter by Philips Image Guided Therapy Corporation in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2017 and Mar 24, 2026 — classified as 1 death, 29 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Material Separation” (59 reports).

1 FDA recall record name at least one of these models by its device 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. 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 .014P RX 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. Jun 13, 2025Class IIOpen, Classified

   Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

   Z-2221-2025 · Recall details · FDA record ↗

Most reported Visions PV .014P RX Digital IVUS Catheter problems

Visions PV .014P RX Digital IVUS Catheter models

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

• Visions PV .014P RX Digital IVUS Catheter 014R

  Catheter, Ultrasound, Intravascular
  1 recall1 death84 reports
• Visions PV .014P RX Digital IVUS Catheter 85910P

  Transducer, Ultrasonic, Diagnostic
  6 reports

Recent Visions PV .014P RX 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.

• MalfunctionMar 24, 2026Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE CATHETER WOULD NOT ADVANCE OVER THE GUIDEWIRE AND BECAME STUCK. THE GUIDEWIRE WAS WIPED DOWN, BUT STILL UNABLE TO ADVANCE THE CATHETER. A NEW CATHETER AND NEW GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, IT WAS OBSERVED THAT THE CATHETER WAS RETURNED INTACT TO THE GUIDEWIRE. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679807 ↗
• MalfunctionMar 20, 2026Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED DISTAL SFA. DURING USE, THE CATHETER WOULD NOT THREAD OVER THE GUIDEWIRE AND BECAME STUCK. THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER AS A SYSTEM. A NEW CATHETER AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656357 ↗
• MalfunctionMar 13, 2026Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED LESION. DURING USE, WHEN THE CATHETER WENT UP AND OVER THE AORTIC ARCH, THE CATHETER BROKE APART. THE CATHETER WAS REMOVED WITH THE SEPARATED PORTION INTACT TO THE NON-PHILIPS GUIDEWIRE. APPROXIMATELY 50 CM HAD SEPARATED BUT ANGIOGRAM CONFIRMED NOTHING WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW VISIONS CATHETER WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594644 ↗
• MalfunctionFeb 4, 2026Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN AN PERIPHERAL PROCEDURE. DURING PREP, THE CATHETER BECAME STUCK ON THE GUIDEWIRE BEFORE ENTERING THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, IT WAS OBSERVED THAT THE CATHETER WAS RETURNED INTACT TO A GUIDEWIRE; INDICATING IT WAS REMOVED AS A SYSTEM. THE USE OF A NEW GUIDEWIRE WAS NEVER REPORTED BY THE FACILITY. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261236 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014 RX CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN A SEVERELY TORTUOUS PROXIMAL ILIAC VESSEL. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE AND COULD NOT BE REMOVED. THEREFORE, A LOT OF FORCE WAS APPLIED, BUT APPROX. 15 CM FROM THE RX PORT TO THE TIP SEPARATED WITHIN THE NON-PHILIPS SHEATH. THE SEPARATED PORTION WAS STUCK ON THE GUIDEWIRE, AND ALL WERE REMOVED TOGETHER. FLUOROSCOPY CONFIRMED NO DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO SHAFT SEPARATION; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930009 ↗
• MalfunctionNov 18, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. AFTER PULLBACK, UPON TAKING THE CATHETER OUT OF THE BODY AND OFF THE GUIDEWIRE, IT FRAYED APART BUT REMAINED INTACT. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL INTERVENTION. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, SHARP EDGES WERE FOUND FROM THE BROKEN MICROCABLES AND EXPOSED CORE WIRE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO SHARP EDGES OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589459 ↗
• InjuryNov 18, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN THE DISTAL SFA. DURING PULLBACK, THE CATHETER BECAME STUCK ON THE NON-PHILIPS GUIDEWIRE. TO MAINTAIN ACCESS, THE SECTION OF THE GUIDEWIRE THAT WAS OUTSIDE OF THE PATIENT WAS CUT OFF, TO REMOVE THE CATHETER AND PROXIMAL PORTION OF THE GUIDEWIRE TOGETHER. THE PROCEDURE WAS COMPLETED BY DELIVERING A NEW CATHETER OVER THE REMAINING PORTION OF THE GUIDEWIRE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER WAS ENTRAPPED, AND ADDITIONAL INTERVENTION WAS REQUIRED FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23588187 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014 RX CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN A SLIGHTLY CALCIFIED ILIAC VESSEL. DURING USE, POST ATHERECTOMY, THE DISTAL TIP SEPARATED WITHIN THE SHEATH. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. A NEW VISIONS CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH 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 23493169 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN THE PROXIMAL SFA. WHEN ATTEMPTING TO CROSS A SEVERELY CALCIFIED LESION, THE CATHETER BECAME KINKED. THUS, THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. A NEW CATHETER 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 THIS WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467893 ↗
• MalfunctionJul 9, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE CATHETER BECAME STUCK ON THE NON-PHILIPS GUIDEWIRE, AND WAS REMOVED AS A SYSTEM. UPON REMOVAL, THE CATHETER GOT DAMAGED WHEN DETACHING FROM THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE. 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 22465070 ↗
• MalfunctionJul 3, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING REMOVAL, THE CATHETER BECAME STUCK ON A NON-PHILIPS GUIDEWIRE AND WAS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW 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 22401121 ↗
• MalfunctionJun 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE IN A SLIGHTLY CALCIFIED PLAQUE LESION IN THE MID TP TRUNK. DURING ADVANCEMENT, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND THE ENTIRE SYSTEM WAS REMOVED AS A UNIT. A NEW CATHETER WAS 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 22319416 ↗
• MalfunctionMay 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED MID AT ARTERY. DURING REMOVAL, THE CATHETER GOT STUCK ON THE NON-PHILIPS GUIDEWIRE, AND THE DISTAL TIP SEPARATED WITHIN THE SHEATH. ALL DEVICES WERE REMOVED AS A SYSTEM, AND IMAGING CONFIRMED NOTHING WAS LEFT IN THE PATIENT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101684 ↗
• MalfunctionMay 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE CATHETER COULD NOT ADVANCE OVER THE NON-PHILIPS GUIDEWIRE. THE CATHETER SHEARED THE GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER AND GUIDEWIRE. NO PATIENT INJURY REPORTED. BASED ON THE DEVICE EVALUATION, THE VISIONS CATHETER WAS RETURNED INTACT TO THE GUIDEWIRE, INDICATING THAT THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. 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 22093217 ↗
• InjuryMay 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A DIALYSIS PATIENT WITH PRE-EXISTING STENT IN THE BRACHIAL VEIN WITH SOME RESTENOSIS. DURING USE, THE DISTAL PORTION OF THE CATHETER BROKE OFF INSIDE THE PATIENT LIKELY DUE TO INTERACTION WITH STENT, AND EMBOLIZED TO EITHER THE RIGHT ATRIUM (RA) OR RIGHT VENTRICLE (RV). A SNARE WAS USED FOR REMOVAL, AND IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER SEPARATED AND EMBOLIZED, REQUIRING ADDITIONAL INTERVENTION TO REMOVE THE DEVICE.

  Patient problems: Embolism/Embolus

  MAUDE report 22091975 ↗

Other Philips Image Guided Therapy Corporation products

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• IntraSight Plus2 models · 0 reports · 1 recall
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