TITAN HD THD155228E.Recalls & reported problems
Medical Components, Inc. · 15.5F X 28CM PRE-CURVED TITAN HD CATHETER FULL SET WITH SIDEHOLES (CUFF 23CM FROM TIP) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908053272), received between Oct 11, 2017 and Nov 4, 2025 — classified as 1 death, 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 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
- Disconnection2
- Leak/Splash2
- Fracture1
Patient problems
- Blood Loss1
- Death1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Fracture; Leak/Splash; Fracture; Leak/Splash
CENTRAL DIALYSIS CATHETER CRACKED AT THE PLASTIC BASE. RUPTURE AT THE JUNCTION OF THE CATHETER BRANCHES CAUSING AIR LEAKAGE INTO THE CIRCUIT AND REQUIRING REPLACEMENT OF THE DIALYSIS CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466031 ↗MalfunctionSep 20, 2019Leak/Splash
PATIENT WAS CONNECTED AS USUAL TO THE DIALYSIS MACHINE. WITHIN A FEW MINUTES, PATIENT NOTIFIED THE NURSE OF SOME BLOOD PRESENT. ANOTHER 10 MINUTES AND IT WAS NOTICED THAT THE CONNECTION TO THE VENOUS BRANCH OF THE CATHETER TO THE BLOODLINE WAS LEAKING. THE DIALYSIS MACHINE WAS STOPPED AND THE VENOUS LUER WAS TIGHTENED. THE ARTERIAL BRANCH WAS CHECKED AND FOUND TO BE CONFORMING.
Patient problems: Blood Loss
MAUDE report 9097797 ↗MalfunctionNov 13, 2018Disconnection; Disconnection
NURSE CHECKS THE CONNECTION OF THE CATHETER AND NOTICED SOME BLOOD ON THE SURGICAL DRAPE AS THE VENOUS CONNECTION WITH THE BLOOD LINE WAS PARTIALLY UNSCREWED. DEVICE WAS NOT REMOVED. NO CLINICAL CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8064828 ↗DeathOct 11, 2017Disconnection; Disconnection
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- 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 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888123404PMozarc 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 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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