HydroMID Maximal Barrier Kit 80H04104Recalls & reported problems
Access Vascular, Inc. · Midline Marked Catheter (Maximal Barrier Kit) · Class 2
All models of HydroMID Maximal Barrier Kit (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00850030354358), received between Mar 11, 2024 and Feb 20, 2026 — classified as 9 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (17 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Fluid/Blood Leak3
Patient problems
- Insufficient Information9
- Inflammation5
- Pain3
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Fluid/Blood Leak
PATIENT ARM SWOLLEN, CATHETER UNABLE TO BE FLUSHED. CATHETER REMOVED AND REPLACED. REMOVED CATHETER OBSERVED TO HAVE A LEAK AND A BLOOD CLOT WAS PRESENT IN THE CATHETER LEAK AND CLOT LOCATIONS NOT STATED. PATIENT STABLE AFTER CATHETER REPLACEMENT.
Patient problems: Implant Pain
MAUDE report 24405798 ↗InjuryDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED PAIN AND POSSIBLE DELAY IN RECEIVING MEDICATION APPROXIMATELY 7 DAYS AFTER CATHETER PLACEMENT. POTENTIAL OCCLUSION AS IT WAS DIFFICULT TO PUSH FLUIDS THROUGH CATHETER. CATHETER REMOVED AND REPLACED WITH ANOTHER CATHETER. SMALL PINHOLE LEAK FOUND IN REMOVED CATHETER.
Patient problems: Implant Pain
MAUDE report 23879155 ↗MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionFeb 7, 2025Break; Break
MalfunctionFeb 7, 2025Break; Break
MalfunctionFeb 7, 2025Break; Break
MalfunctionFeb 6, 2025Break; Break
A KINK AND A RUPTURE IN THE MIDLINE CATHETER.
Patient problems: Insufficient Information
MAUDE report 21327238 ↗MalfunctionJan 28, 2025Break; Break
CUSTOMER REPORTED A KINK AND FRACTURE IN A MIDLINE.
Patient problems: Insufficient Information
MAUDE report 21258420 ↗MalfunctionDec 9, 2024Break; Break
MalfunctionDec 9, 2024Break; Break
MalfunctionNov 26, 2024Break; Break
REPORT OF A MIDLINE CATHETER BREAK NEAR THE SUTURE WING.
Patient problems: Insufficient Information
MAUDE report 20783314 ↗MalfunctionNov 8, 2024Break; Break
MalfunctionNov 8, 2024Break; Break
InjuryOct 24, 2024Break; Break
CUSTOMER REPORTED A FRACTURED MIDLINE CATHETER.
Patient problems: Inflammation
MAUDE report 20525241 ↗InjuryOct 10, 2024Break; Break
CUSTOMER REPORTED A FRACTURED MIDLINE CATHETER.
Patient problems: Inflammation
MAUDE report 20423043 ↗InjurySep 24, 2024Break; Break
REPORT OF A RUPTURE IN A MIDLINE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294377 ↗InjuryJul 11, 2024Break; Break
InjuryMay 9, 2024Break; Break
CUSTOMER REPORTED A BREAK IN A MIDLINE.
Patient problems: Insufficient Information
MAUDE report 19279569 ↗InjuryMay 9, 2024Break; Break
CUSTOMER REPORTED A BREAK IN A MIDLINE.
Patient problems: Insufficient Information
MAUDE report 19279284 ↗InjuryMar 11, 2024Break; Break
CUSTOMER REPORTED A MIDLINE CATHETER THAT WAS FRACTURED.
Patient problems: Pain
MAUDE report 18873957 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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