MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERMEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETER THD155024Recalls & reported problems
Medical Components, Inc. · 15.5F X 24CM Titan HD15.5F X 24C CATHETERCATHETER (CUFF 19CM FROM TIP)(CUFF 19CM F · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908129304), received between Jun 27, 2022 and Mar 5, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
1 FDA recall record name this device's identifier.
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 18, 2026.
Reports received per month
Recalls naming this device
- Jul 27, 2020Class IITerminated
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
Z-2940-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Crack1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Crack; Crack
CATHETER WAS INSERTED ON (B)(6) 2024 AND NEEDED TO BE EXCHANGED ON (B)(6) 2024 DUE TO A CRACK IN THE VENOUS LUMEN TUBING CLOSEST TO THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18835830 ↗DeathJun 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PATIENT WAS ON DIALYSIS, BEING TREATED AT HOME. PATIENT WAS BOTHERED BY DRESSING, MOTHER OF PATIENT WAS CHANGING DRESSING AND CUT CATHETER. PATIENT BLED TO DEATH.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14829205 ↗
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- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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