N/A (REF 85900P)Recalls & reported problems
Innovative Health LLC · Eagle Eye Platinum RX Digital IVUS Catheter 150 cm 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 10841898131349), received between Mar 20, 2025 and Mar 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Detachment of Device or Device Component1
- 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.
MalfunctionMar 20, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Split, Cut or Torn
ON (B)(6) 2025, THE DEVICE WAS RETURNED WITH A NOTE STATING, "CATHETER SEPARATED". NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653301 ↗
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.