FREE FLOW IJ MFFS1515IJRecalls & reported problems
Medical Components, Inc. · 15.5F X 15CM IJ FREE FLOW CATHETER SET W/STYLET · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908030464), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 death.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Air Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 12, 2023Break; Break
THE PATIENT PASSED AWAY IN THE HOSPITAL. AFTER AUTOPSY, A LARGE QUANTITY OF AIR HAS BEEN LOCATED IN THE RIGHT VENTRICLE AND THIS IS THE PROBABLE CAUSE OF DEATH. THE DIALYSIS CATHETER HAS BEEN QUARANTINED BECAUSE THE CATHETER COULD BE THE CAUSE OF THE AIR EMBOLISM. AFTER INVESTIGATION, THERE SEEMS TO BE A CATHETER DEFECT. THIS TYPE OF DEFECT ABNORMAL AND COULD BE DUE TO EXTERNAL FACTORS.
Patient problems: Air Embolism
MAUDE report 17730596 ↗
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- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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