HydroPICC Dual Lumen 80H02104Recalls & reported problems
Access Vascular, Inc. · HydroPICC Marked 5Fr Dual Lumen Maximal Barrier Kit · Class 2 · Implant
All models of HydroPICC Dual Lumen (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850030354334), received between Nov 21, 2024 and Sep 3, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 reports).
2 other recalls cover devices cleared under the same FDA submission (K213550); they may or may not involve this specific model.
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
- Break5
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information6
- Reduced Blood Flow1
Recent adverse event reports
The 7 most recent of 7 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213550. One submission often covers many models, so check the product and lot details in each record.
- Z-0115-2024 · Aug 31, 2023 · Open, ClassifiedHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Z-0114-2024 · Aug 31, 2023 · Open, ClassifiedHydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Other Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC Catheter 3275118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days272 reports
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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