Visions PV .035 Digital IVUS Catheter 81234Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00845225002596), received between Jul 13, 2018 and Jan 7, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 13, 2022Open, Classified

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

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

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJun 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, WHILE ADVANCING THE VISIONS PV .035 CATHETER TO THE ILIAC ARTERY, THE TIP OF THE CATHETER SEPARATED IN TWO PIECES. ATTEMPTS TO SNARE/JAIL THE SEPARATED TIP WAS UNSUCCESSFUL. THE TIP WAS LEFT FREE FLOATING AND RETAINED IN THE PULMONARY ARTERY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE IT WAS DETERMINED UNSAFE TO RETRIEVE THE TIP. THE PATIENT'S CONDITION TODAY IS STABLE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION. ADDITIONAL INTERVENTION WAS UNSUCCESSFUL, THUS WAS RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14704432 ↗
• InjuryDec 2, 2021Entrapment of Device; Material Split, Cut or Torn; Entrapment of Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE MANUFACTURER'S CATHETER SHAFT RIPPED APART, BUT REMAINED INTACT TO THE INTERNAL WIRES. DURING PULLBACK, THE CATHETER WAS UNABLE TO BE REMOVED; THEREFORE, THE CATHETER WAS CUT MID SHAFT. A SECOND ACCESS LOCATION IN THE UPPER ARM WAS REQUIRED, AND USED A SNARE TO REMOVE THE DISTAL HALF OF THE CATHETER, SUCCESSFULLY. NO PIECE OF THE CATHETER WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON MANUFACTURER'S BALLOON AND NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE DISTAL PORTION OF THE MANUFACTURER'S CATHETER SHAFT RIPPED APART AND ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921677 ↗
• InjuryMar 26, 2020Material Separation; Material Separation

  THIS FOLLOW-UP SUPPLEMENTAL REPORT #1 IS BEING SUBMITTED TO CORRECT AN INADVERTENT ENTRY ERROR IN BLOCK G4 IN THE INITIAL REPORT SUBMISSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9883816 ↗
• MalfunctionOct 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7963415 ↗
• InjuryOct 3, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, THE END OF THE MANUFACTURER'S DEVICE BROKE OFF IN THE PATIENT. NO OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE TIP OF THE MANUFACTURER'S DEVICE SEPARATED AND REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7932733 ↗
• InjuryOct 3, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, THE END OF THE MANUFACTURER'S DEVICE BROKE OFF IN THE PATIENT. NO OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE THE TIP OF THE MANUFACTURER'S DEVICE SEPARATED AND REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7932723 ↗
• MalfunctionSep 28, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A THERAPEUTIC PERIPHERAL PROCEDURE, THE IMAGE ON THE SCREEN WAS FLICKERING. THE MANUFACTURE'S CATHETER DEVICE WAS DISCONNECTED AND RECONNECTED; HOWEVER, THE IMAGE WAS POOR. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OCCURRED. VISUAL AND MICROSCOPIC INSPECTION AND AN IMAGE TEST WERE PERFORMED ON THE RETURNED DEVICE. THE DISTAL TIP WAS DEFORMED. THERE WAS LIFTED ADHESIVE AT THE DISTAL FILLET. A PORTION OF ADHESIVE FROM BOTH THE PROXIMAL AND DISTAL FILLET WAS MISSING FROM THE DEEP SCRATCHES. THE PROBABLE CAUSE OF THE MISSING ADHESIVE COULD NOT BE DETERMINED THROUGH THE INVESTIGATION. STRAIN, IMPACT, AND FORCES ASSOCIATED WITH USE CAN AFFECT THE INTEGRITY OF THE DEVICE. IT COULD NOT BE DETERMINED HOW AND WHEN THE CAUSE OF THE FAILURE OCCURRED. 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 AND IT COULD NOT CONCLUSIVELY BE DETERMINED WHEN THE SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7917335 ↗
• MalfunctionJul 13, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, DURING A DIAGNOSTIC PERIPHERAL PROCEDURE, THE IMAGE WAS LOST UPON ENTERING THE PATIENT. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. VISUAL AND MICROSCOPIC INSPECTION AND AN IMAGE TEST WERE PERFORMED ON THE RETURNED DEVICE. THE DEVICE TIP WAS DEFORMED. THERE WAS A SMALL PINHOLE IN THE PROXIMAL FILLET, APPROXIMATELY 0.04 SQUARE MILLIMETERS IN SIZE, APPROXIMATELY 19 MM FROM THE DISTAL END OF THE DEVICE TIP. THE INNER MEMBER WAS BUNCHED. ALL PORTIONS OF THE DEVICE WERE ACCOUNTED FOR. THE DEVICE WAS CONNECTED TO THE LAB IMAGING SYSTEM FOR AN IMAGE TEST. THE DEVICE WAS NOT RECOGNIZED AND THE SYSTEM DISPLAYED A "NO CATHETER" MESSAGE. THE DEVICE WAS FURTHER INSPECTED BY AN ADVANCE ENGINEER, AND IT IS PROBABLE THAT THE PIN HOLE OBSERVED IN THE PROXIMAL FILLET IS THE RESULT OF AN AIR BUBBLE OR VOID ON THE SURFACE OF THE ADHESIVE RUPTURING WHEN IT WENT ACROSS THE STENT OR A CALCIFIED VESSEL. THIS IS SUPPORTED BY OBSERVATIONS OF STRIATIONS ACROSS THE SURFACE OF THE PROXIMAL FILLET OVER THE VOID. THE PROBABLE CAUSE OF THE REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7688343 ↗