Hickman 0600360Recalls & reported problems
Bard Access Systems, Inc. · Hickman 12.5 Fr Triple-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff · Class 2 · Implant
All models of Hickman (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741051784), received between Aug 13, 2021 and Jan 23, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection2
- Material Puncture/Hole2
- Break1
- Fluid/Blood Leak1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING A BARD HICKMAN TRIPLE LUMEN CATHETER. IT WAS REPORTED THAT A SPLIT/TEAR APPROXIMATELY 1CM LONG ON THE LUMEN FROM THE BASE OF THE BIFURCATION BRANCH/PLASTIC HUB WHERE THE LUMENS CONVERGE. SALINE AND BLOOD WERE OBSERVED OOZING FROM THE DAMAGED AREA. THE CATHETER WAS CLAMPED, THE PHYSICIAN ASSESSED THE SITUATION, AND AN ORDER WAS GIVEN TO STOP USING THE DEVICE. THE DEVICE WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158907 ↗MalfunctionNov 27, 2025Material Puncture/Hole; Material Puncture/Hole
A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING HICKMAN CV CATHETER, TRIPLE-LUMEN, 12.5F. IT WAS REPORTED THAT DURING USE OF A HICKMAN CATHETER PLACED ON APR 11, 2025, A HOLE WAS OBSERVED IN THE MATERIAL AT THE TRANSITION FROM THE HARD TO SOFT SECTION OF THE CATHETER, INDICATING DAMAGE TO THE CATHETER WALL. ON (B)(6) 2025, THE ISSUE WAS IDENTIFIED WHILE THE CATHETER WAS IN THE FEMORAL VEIN AND BEING USED DAILY FOR TPV ADMINISTRATION CLOSED WITH TAUROSEPT 2%. THE CATHETER WAS SUBSEQUENTLY REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664172 ↗MalfunctionDec 6, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CLAMP OF THE CATHETER ALLEGEDLY OPENED FASTER THAN BEFORE AND CAME OFF EASILY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18273142 ↗MalfunctionDec 1, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CLAMPS ALLEGEDLY OPEN FASTER THAN BEFORE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18245527 ↗InjuryAug 13, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A HOLE. IT WAS FURTHER REPORTED THAT ADDITIONAL INTERVENTIONAL WAS REQUIRED TO THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12317561 ↗InjuryAug 13, 2021Break; Break
IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT ADDITIONAL INTERVENTIONAL WAS REQUIRED TO PATIENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12317560 ↗
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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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