HydroPICC Maximal Barrier KitRecalls & reported problems across all models
Access Vascular, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one HydroPICC Maximal Barrier Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 2 models of HydroPICC Maximal Barrier Kit by Access Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2023 and Nov 21, 2025 — classified as 9 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (8 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
HydroPICC 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.
- Mar 3, 2023Open, Classified
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Z-1605-2023 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported HydroPICC Maximal Barrier Kit problems
Device problems
- Break8
- Fluid/Blood Leak3
- Improper or Incorrect Procedure or Method3
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information6
- Inflammation4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Clinical Signs, Symptoms or Conditions2
- Pain1
HydroPICC Maximal Barrier Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HydroPICC Maximal Barrier Kit 80001004Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall7 reports
- HydroPICC Maximal Barrier Kit 80H01104Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days9 reports
Recent HydroPICC 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.
MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
PICC CATHETER LEAKED/RUPTURED APPROXIMATELY ONE WEEK AFTER PLACEMENT. CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER.
Patient problems: Insufficient Information
MAUDE report 23622345 ↗MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionApr 30, 2025Break; Break
MalfunctionApr 23, 2025Break; Break
MalfunctionJan 22, 2025Break; Break
MalfunctionDec 13, 2024Break; Break
CUSTOMER REPORTED A HYDROPICC LINE THAT KINKED AND FRACTURED.
Patient problems: Pain
MAUDE report 20926334 ↗InjurySep 10, 2024Break; Break
OBSERVED A BREAK/CUT IN A CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20184918 ↗InjuryAug 9, 2024Break; Break
REPORT OF A CATHETER BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19952143 ↗InjuryMay 20, 2024Break; Break
InjuryMar 28, 2024Break; Break
CUSTOMER REPORTED A PICC CATHETER THAT WAS FRACTURED.
Patient problems: Inflammation
MAUDE report 18998133 ↗InjuryOct 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED A RUPTURED HYDROPICC.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17969817 ↗InjuryApr 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CUSTOMER REPORTED A "RUPTURED" PICC LINE.
Patient problems: Insufficient Information
MAUDE report 16700696 ↗InjuryJan 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINANT REPORTED A PICC LINE THAT NEEDED TO BE REMOVED DUE TO SWELLING AND REDNESS. UPON PULLING THE LINE AND EXAMINING IT, A DEFECT WAS OBSERVED.
Patient problems: Inflammation
MAUDE report 16234060 ↗InjuryJan 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CATHETER LEAK/IMPERFECTION IDENTIFIED POST REMOVAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16158462 ↗
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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