HydroPICC Dual LumenRecalls & 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 HydroPICC Dual Lumen model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 3 models of HydroPICC Dual Lumen by Access Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2023 and Sep 3, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
HydroPICC Dual Lumen 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.
- Aug 31, 2023Open, Classified
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Z-0115-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
- Aug 31, 2023Open, Classified
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Z-0114-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported HydroPICC Dual Lumen problems
Device problems
- Break6
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information6
- Inflammation1
- Reduced Blood Flow1
- Thrombosis/Thrombus1
HydroPICC Dual Lumen models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HydroPICC Dual Lumen 80002002Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
- HydroPICC Dual Lumen 80002004Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
- HydroPICC Dual Lumen 80H02104Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days7 reports
Recent HydroPICC Dual Lumen adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE PICC WAS PLACED AT A REHAB CENTER. AFTER APPROXIMATELY 10 DAYS ON INDWELLING, PATIENT WAS TRANSPORTED TO HOSPITAL FOR POOR BLOOD FLOW. PATIENT UNDERWENT ULTRASOUND AND A POSSIBLE KINK WAS IDENTIFIED. PICC LINE WAS REMOVED AND A TEAR IN THE CATHETER WAS OBSERVED AT 16CM LINE. PATIENT FINE AFTER PICC REMOVAL AND REPLACEMENT.
Patient problems: Reduced Blood Flow
MAUDE report 22957616 ↗MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
COMPLAINANT NOTED THAT INFUSATE WAS LEAKING FROM INSERTION SITE DURING PROCEDURE. A BREAK IN THE CATHETER WAS OBSERVED ONCE THE CATHETER WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 22816330 ↗MalfunctionApr 4, 2025Break; Break
MalfunctionFeb 7, 2025Break; Break
MalfunctionFeb 7, 2025Break; Break
MalfunctionNov 29, 2024Break; Break
CUSTOMER REPORTED A BREAK IN A DUAL LUMEN HYDROPICC.
Patient problems: Insufficient Information
MAUDE report 20812291 ↗MalfunctionNov 21, 2024Break; Break
REPORT OF A LEAKING/ FRACTURED CATHETER.
Patient problems: Insufficient Information
MAUDE report 20746260 ↗InjuryMay 24, 2024Break; Break
REPORT OF A LEAK/BREAK IN A DUAL LUMEN CATHETER.
Patient problems: Inflammation
MAUDE report 19392189 ↗InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DVT REPORTED FOR PATIENT WITH PICC-251 DEVICE.
Patient problems: Thrombosis/Thrombus
MAUDE report 16685340 ↗
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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