Titan HD THD155628Recalls & reported problems
Medical Components, Inc. · 15.5F X 28CM PRE-CURVED Titan HD CATHETER FULL SET WITHOUT SIDEHOLES (CUFF 23CM FROM TIP) · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908053708), received between Jun 14, 2017 and Nov 23, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Disconnection1
Patient problems
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2021Disconnection; Disconnection
WHEN ENDING THE TREATMENT BY REINFUSION, THE NURSE SUDDENLY HEARD A "PSSST" SOUND. THE NURSE SAW IMMEDIATELY THAT THE CATHETER HAD COME LOOSE. THE NURSE CLOSED THE CLAMPS AND PUSHED THE CATHETER BACK TOGETHER OUT OF INTUITIVE REACTION. THIS PATIENT HAD MINIMAL LOSS OF BLOOD BECAUSE THE NURSE REACTED IN TIME. THE PATIENT ALSO RECEIVED A SINGLE DOSE OF ANTIBIOTICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12862834 ↗InjuryJun 14, 2017Device Dislodged or Dislocated; Detachment Of Device Component; Device Dislodged or Dislocated
FEMALE BLUE (VENOUS) WHITE LUER CONNECTOR DETACHED FROM EXTENSION TUBING DURING DIALYSIS BLOOD LOSS OF 100-200 MLS.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 6639550 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.