HydroMID Maximal Barrier Kit 80004104Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850030354211), received between Jul 27, 2023 and Jul 18, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Insufficient Device Problem Information2
Patient problems
- Inflammation2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
- Vasculitis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2024Break; Break
THE USER PIERCED THE CATHETER WITH THE GUIDEWIRE.
Patient problems: Inflammation
MAUDE report 19776449 ↗InjuryApr 16, 2024Break; Break
InjuryJan 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER REPORTED A MIDLINE THAT WAS FOUND TO HAVE A HOLE IN THE CATHETER WALL AFTER REMOVAL.
Patient problems: Inflammation
MAUDE report 18566786 ↗InjuryOct 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED A PATIENT WITH A HYDROMID THAT DEVELOPED THROMBUS.
Patient problems: Thrombosis/Thrombus
MAUDE report 18041238 ↗InjuryOct 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED A PATIENT WITH A HYDROMID THAT DEVELOPED THROMBUS.
Patient problems: Vasculitis
MAUDE report 18041201 ↗InjuryJul 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER REPORTED A MIDLINE WITH A LEAK IN THE EXTENSION TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17404501 ↗
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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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