N/A (REF 014R)Recalls & reported problems
Innovative Health LLC · Visions PV .014P RX Digital IVUS Catheter 150cm 3.5F · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841898134418), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Difficult to Remove; Material Separation; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Material Split, Cut or Torn
THE DEVICE WAS REPORTED TO HAVE THE SHEATH OF THE TIP SHEARED OFF, CAUSING THE SUPPORT CABLE TO BE VISIBLE. IT WAS REPORTED THAT ALL DEVICE COMPONENTS WERE RETRIEVED AND THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639291 ↗
Other Reprocessed Intravascular Ultrasound Catheter devices
- MEDLINE D087031RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls5 reports
- MEDLINE 10135910RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- MEDLINE 10135936RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
- MEDLINE 10438577RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439236RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439011RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.