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

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00845225002848), received between Sep 11, 2017 and Mar 24, 2026 — classified as 1 death, 28 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Separation” (54 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. 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 problems

Recent adverse event reports

The 25 most recent of 84 reports, 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 ↗
• InjuryMay 23, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN THE MID AORTA. DURING THE FINAL IVUS RUN, THE CATHETER PROLAPSED/KINKED AND GOT STUCK ON THE NON-PHILIPS GUIDEWIRE. THE CATHETER WAS CUT TO REMOVE FROM THE PATIENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER WAS ENTRAPPED, AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081475 ↗
• InjuryMay 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING ADVANCEMENT, THE DISTAL TIP GOT TRAPPED IN THE CALCIFIED LESION AND COULD NOT BE REMOVED. DURING REMOVAL, FORCE WAS APPLIED AND THE DISTAL SHAFT GOT DISLODGED, BUT AN EN SNARE WAS USED TO REMOVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW VISIONS CATHETER. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER SHAFT SEPARATED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071232 ↗
• MalfunctionMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED DURING A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED MID-POPLITEAL. DURING PULL BACK, THE CATHETER BECAME STUCK ON THE NON-PHILIPS GUIDEWIRE, WHICH REQUIRED MORE EFFORT TO REMOVE. HOWEVER, THE DISTAL END OF THE CATHETER SEPARATED, AND BOTH THE CATHETER (INCLUDING THE SEPARATED PORTION) AND GUIDEWIRE WERE REMOVED AS A SYSTEM. IMAGING CONFIRMED THAT NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY WAS REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047687 ↗
• MalfunctionMay 1, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED MID SFA. DURING REMOVAL, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE AND REMOVED TOGETHER. A NEW VISIONS 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 21942667 ↗
• MalfunctionApr 28, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED DISTAL PT. WHEN THE CATHETER WAS ADVANCED TO THE LESION, RESISTANCE WAS ENCOUNTERED. THE CATHETER WAS PULLED BACK BUT GOT STUCK ON A NON-PHILIPS GUIDEWIRE; THUS, WAS REMOVED TOGETHER. HOWEVER, IT WAS NOTICED THAT THE DISTAL PORTION OF THE CATHETER SEPARATED AS IT WAS COMING OUT OF THE INTRODUCER SHEATH BUT WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER SEPARATED AND WAS 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 21923178 ↗
• MalfunctionFeb 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A DIAGNOSTIC PERIPHERAL PROCEDURE. DURING USE, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND BOTH 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 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 21453204 ↗
• MalfunctionFeb 12, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A VISIONS PV .014P RX CATHETER WAS USED IN A THERAPEUTIC PERIPHERAL PROCEDURE. DURING ADVANCEMENT, THE TIP OF THE CATHETER BECAME STUCK ON THE 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 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 21370432 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS PV .014 RX CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING PULLBACK FROM THE RIGHT COMMON FEMORAL TO THE RIGHT COMMON ILIAC, THE DISTAL TIP SEPARATED BUT REMAINED INTACT TO THE NON-PHILIPS GUIDEWIRE. AT THIS TIME, THERE WAS NO ATTEMPT TO REMOVE FROM THE PATIENT. INSTEAD, A RX BALLOON WAS LOADED FROM THE POST TIBIAL ARTERY, THEN PUSHED UP TO THE RIGHT ILIAC TO ACCOMPLISH THE ANGIOPLASTY. AFTERWARDS, BOTH THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM. THE CASE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS DISTAL TIP SEPARATED; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368546 ↗
• InjuryFeb 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A VISIONS CATHETER WAS USED IN A PERIPHERAL DIAGNOSTIC PROCEDURE. DURING REMOVAL, THE DISTAL TIP SEPARATED, BUT A SNARE WAS USED TO RETRIEVE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE CATHETER. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VISIONS CATHETER TIP SEPARATED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349337 ↗
• MalfunctionFeb 3, 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 GOT STUCK ON A NON-PHILIPS GUIDEWIRE, AND BOTH 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 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 21300480 ↗