HydroMID Maximal Barrier KitRecalls & reported problems across all models
Access Vascular, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one HydroMID Maximal Barrier Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 2
We found 3 models of HydroMID Maximal Barrier Kit by Access Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2022 and Feb 20, 2026 — classified as 17 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (19 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
HydroMID Maximal Barrier Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 22, 2022Open, Classified
Label with the incorrect component listed on the inner kit Tyvek header bag
Z-1156-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 22, 2022Open, Classified
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Z-1155-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported HydroMID Maximal Barrier Kit problems
Device problems
- Break19
- Appropriate Device Problem Term/Code Not Available3
- Fluid/Blood Leak3
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Off-Label Use1
Patient problems
- Insufficient Information12
- Inflammation7
- Pain3
- Thrombosis/Thrombus3
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Vasculitis1
HydroMID Maximal Barrier Kit models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HydroMID Maximal Barrier Kit 80004004Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2 recalls5 reports
- HydroMID Maximal Barrier Kit 80H04104Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days20 reports
- HydroMID Maximal Barrier Kit 80004104Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days6 reports
Recent HydroMID Maximal Barrier Kit adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Access Vascular, Inc. products
All Access Vascular, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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