Centurion I300F85Recalls & reported problems
Centurion Medical Products Corporation · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10653160248538), received between Sep 24, 2026 and Sep 29, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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, 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
- Material Twisted/Bent4
- Material Deformation2
- Mechanical Problem2
- Backflow1
- Deformation Due to Compressive Stress1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939887 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939617 ↗MalfunctionSep 29, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938917 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938292 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported that "Doctor is facing issues in loading Swan-Ganz in contamination shield, they observed contamination shield has kink due to which Swan-Ganz catheter is not passing through."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937444 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937351 ↗MalfunctionSep 29, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936649 ↗MalfunctionSep 29, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935120 ↗MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934640 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924273 ↗MalfunctionSep 28, 2026Backflow
It was reported that, "Facing back flow of blood from side lumen while using it on the patients."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914838 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that Introflex Introducer Set was defective as one way valve was not functional and fluid (IV & Blood) was leaking out.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50884034 ↗
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- Medline Industries, Inc. I505BF9CCenturion Medical Products Corporation · Catheter introducer kit1 recall0 reports
- Medline Industries, Inc. STCVC2020Centurion Medical Products Corporation · Catheter introducer kit1 recall0 reports
- Medline Industries, Inc. I550BF6CCenturion Medical Products Corporation · Catheter introducer kit1 recall0 reports
- Centurion I505BF9Centurion Medical Products Corporation · Catheter introducer kit2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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