HydroPICC Maximal Barrier Kit 80H01104Recalls & reported problems
Access Vascular, Inc. · Peripherally Inserted Central Marked Catheter (Maximal Barrier Kit) · Class 2
All models of HydroPICC Maximal Barrier Kit (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850030354303), received between Mar 28, 2024 and Nov 21, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
4 other recalls cover devices cleared under the same FDA submission (K193015); 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
- Break6
- Fluid/Blood Leak3
Patient problems
- Insufficient Information5
- Inflammation3
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, 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 ↗InjuryMay 20, 2024Break; Break
InjuryMar 28, 2024Break; Break
CUSTOMER REPORTED A PICC CATHETER THAT WAS FRACTURED.
Patient problems: Inflammation
MAUDE report 18998133 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K193015. One submission often covers many models, so check the product and lot details in each record.
- Z-1605-2023 · Mar 3, 2023 · Open, ClassifiedHydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Z-1130-2023 · Dec 16, 2022 · Open, ClassifiedHydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
- Z-1131-2023 · Dec 16, 2022 · Open, ClassifiedHydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
- Z-0199-2023 · Feb 24, 2021 · TerminatedScalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
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.
How reports and recalls are matched · Editorial policy · Report an error on this page