Pioneer Plus CatheterRecalls & reported problems across all models

We found 2 models of Pioneer Plus Catheter by Philips Image Guided Therapy Corporation in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2017 and Sep 15, 2026 — classified as 14 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 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. 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

Most reported Pioneer Plus Catheter problems

Pioneer Plus Catheter models

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

• Pioneer Plus Catheter PPLUS120

  Transducer, Ultrasonic, Diagnostic
  41 reports
• Pioneer Plus Catheter PPLUS120

  Transducer, Ultrasonic, Diagnostic
  23 reports

Recent Pioneer Plus Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Separation

  It was reported that a Pioneer Plus Catheter was used in a peripheral procedure. During removal, it was noted that the distal tip separated but remained intact to the guidewire. The entire catheter was removed from the patient with no additional intervention required. No patient injury reported. This Product Problem is being submitted because the Pioneer Plus Catheter tip separated. There is a potential for harm if the malfunction were to recur.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779776 ↗
• MalfunctionAug 12, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223754 ↗
• MalfunctionJul 14, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816841 ↗
• MalfunctionMay 19, 2026No Display/Image

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE. DURING USE, RECOGNITION WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS LOST WHEN ADVANCING TO THE VESSEL. THE CATHETER WAS UNPLUGGED/PLUGGED, BUT STILL DID NOT WORK. THE USE OF THE CATHETER WAS ABORTED AND THE PHYSICIAN DECIDED TO PERFORM SURGERY TO COMPLETE THE PROCEDURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PIONEER CATHETER COULD NOT BE USED; THEREFORE, SURGICAL INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222666 ↗
• MalfunctionMay 14, 2026Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A DISTAL SFA. DURING ADVANCEMENT OVER A NON-PHILIPS GUIDEWIRE, RESISTANCE WAS FELT AND THE CATHETER COULD NOT BE ADVANCED OR RETRACTED. UNDER FLUOROSCOPY, THE GUIDEWIRE APPEARED PROLAPSED AND KINKED; THEREFORE, THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER WITHIN THE SHEATH. THE PROCEDURE WAS ABORTED AND THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND FOR DELAY OF PROCEDURE. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177191 ↗
• MalfunctionApr 23, 2026Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING ADVANCEMENT, THE TIP OF THE NEEDLE GOT CAUGHT, EXPOSING THE NEEDLE AND COULD NOT BE RETRACTED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WAS TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974950 ↗
• MalfunctionApr 7, 2026Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, THE CATHETER WAS DEFECTIVE DUE TO THE ULTRASOUND NOT WORKING. UPON REMOVAL, THE CATHETER BECAME TANGLED/KINKED, AND THE GUIDEWIRE TORE THROUGH PART OF THE CATHETER; THEREFORE, REMOVED TOGETHER. AT THIS POINT, THE PHYSICIAN DECIDED IT WAS BETTER TO DISCONTINUE THE PROCEDURE AND BRING THE PATIENT BACK AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND FOR DELAY OF PROCEDURE. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811457 ↗
• MalfunctionMar 30, 2026No Display/Image

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A THERAPEUTIC PERIPHERAL PROCEDURE IN SEVERELY CALCIFIED SFA. DURING USE, WHEN THE CATHETER WAS ADVANCED TO THE OCCLUSION, THE IVUS IMAGE WAS LOST. THE SYSTEM WAS REBOOTED, CATHETER WAS UNPLUGGED/PLUGGED; HOWEVER, THE IMAGE REMAINED LOST. THE PROCEDURE COULD NOT BE COMPLETE BECAUSE THEY COULD NOT CROSS BACK INTO THE TRUE LUMEN WITHOUT THE CATHETER. THE PATIENT WILL BE BROUGHT BACK FOR TREATMENT AT A LATER DATE. NO PATIENT INJURY 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 24733279 ↗
• MalfunctionMar 6, 2026Difficult to Advance

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A MODERATELY CALCIFIED DISTAL SFA. DURING USE, A NON-PHILIPS GUIDEWIRE WAS UNABLE TO PASS THROUGH THE CATHETER LUMEN. THE PROCEDURE WAS ABORTED AND THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED AND THE PROCEDURE WAS ABORTED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537293 ↗
• InjuryMar 4, 2026Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A CTO LESION. DURING USE, THE CATHETER BECAME STUCK ON A NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED TOGETHER. A NEW GUIDEWIRE WAS INSERTED, AND UPON ADVANCING A NEW PIONEER PLUS CATHETER, THE CATHETER COULD NOT BE RECOGNIZED. AN ATTEMPT TO DISCONNECT/RECONNECT AND SHUTTING/RESTARTING THE SYSTEM WAS PERFORMED WITH NO SUCCESS. THE PROCEDURE WAS ABORTED DUE TO THE FAILURE ON THE SECOND ATTEMPT AND PATIENT EXPERIENCED A DISSECTION. THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE. THE PATIENT REMAINS STABLE WITH NON-HEALING WOUNDS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED A DISSECTION, CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND THE PATIENT WILL BE BROUGHT BACK FOR FURTHER TREATMENT; RESULTING IN A DELAY OF THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24508148 ↗
• MalfunctionFeb 9, 2026Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED FOR A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED SFA. DURING ADVANCEMENT, THE CATHETER GOT STUCK ON THE NON-PHILIPS WIRE; THEREFORE, REMOVED AS A SYSTEM. ADDITIONALLY, IT WAS NOTED THAT THE CATHETER HAD A BUMP ON THE MONORAIL, WHERE THE WIRE COMES OUT. A NEW PIONEER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS 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 24300444 ↗
• InjuryJan 8, 2026Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED DURING A PERIPHERAL PROCEDURE. WHEN REMOVING THE CATHETER FROM THE NON-PHILIPS GUIDEWIRE (BOSTON SCIENTIFIC THRUWAY), THE TIP OF THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION, BUT IT REMAINED IN THE DISSECTED PLAIN OF THE SFA. THE CAUSE OF THE GUIDEWIRE SEPARATION IS UNKNOWN; HOWEVER, THERE WAS NO ALLEGED MALFUNCTION OF THE PIONEER PLUS CATHETER. THIS ADVERSE EVENT IS BEING SUBMITTED CONSERVATIVELY BECAUSE IT IS UNKNOWN IF THE SHARP EDGE OF THE NEEDLE POSSIBLY CAUSED OR CONTRIBUTED TO THE GUIDEWIRE SEPARATION, REQUIRING INTERVENTION BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24015952 ↗
• MalfunctionJan 6, 2026Entrapment of Device; Sharp Edges

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE. DURING REMOVAL, THE NEEDLE INSIDE THE CATHETER COULD NOT BE RETRACTED. AN ATTEMPT TO RETRACT THE NEEDLE WAS UNSUCCESSFUL DUE TO THE KINKED GUIDEWIRE THAT BECAME STUCK; THEREFORE, REMOVED ALL TOGETHER. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE AND REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981056 ↗
• MalfunctionDec 5, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED SFA. DURING ADVANCEMENT OVER A NON-PHILIPS GUIDEWIRE, RESISTANCE WAS ENCOUNTERED AND COULD NOT BE ADVANCED FURTHER. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER WITH THE INTENTION OF PRE-DILATING THE SUB-INTIMAL CHANNEL; HOWEVER, THE CATHETER BECAME STUCK ON THE GUIDEWIRE, THUS WAS REMOVED TOGETHER. UPON REMOVAL, IT APPEARED THAT THE GUIDEWIRE TORE THROUGH PART OF THE CATHETER EXIT PORT. ON THE TABLE, WHEN TRYING TO REMOVE THE CATHETER FROM THE GUIDEWIRE, THE GUIDEWIRE BROKE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS BROUGHT BACK AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM, AND THE PATIENT WAS BROUGHT BACK AT A LATER DATE, RESULTING IN A DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23734532 ↗
• MalfunctionNov 26, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PIONEER PLUS CATHETER WAS USED IN A PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED SFA. DURING USE, THE CATHETER GOT STUCK ON A NON-PHILIPS GUIDEWIRE; THEREFORE, WAS REMOVED AS A SYSTEM (MDR 3008363989-2025-00148). HOWEVER, DURING REMOVAL, THE 7F NON-PHILIPS INTRODUCER SHEATH BEGAN TO COIL BACK BUT WAS ABLE TO BE REMOVED FROM THE INTRODUCER SHEATH. UPON REMOVAL FROM THE PATIENT, THE DISTAL TIP SEPARATED WHEN IT WAS BEING REMOVED FROM THE GUIDEWIRE. A NEW PIONEER CATHETER WAS OPENED; HOWEVER, WHEN IT WAS ADVANCED, THE RE-ENTRY GUIDEWIRE WAS NOT INSIDE THE LUMEN OF THE RE-ENTRY NEEDLE, RATHER IT WAS UP BY THE RX EXIT PORT. SINCE RE-ENTRY WAS NOT ACHIEVED, BOTH THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SYSTEM (MDR 3008363989-2025-00149). AFTER REMOVAL FROM THE PATIENT, VISUAL INSPECTION FOUND THE NEEDLE WAS LODGED AT THE DISTAL TIP, JUST BEHIND THE IVUS TRANSDUCER. A THIRD PIONEER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PIONEER PLUS 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 23658532 ↗

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