HydroPICC Maximal Barrier Kit 80001004Recalls & reported problems
Access Vascular, Inc. · Peripherally Inserted Central 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00862559000487), received between Jan 13, 2023 and Sep 10, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 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
Recalls naming this device
- Mar 3, 2023Class IIOpen, 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 problems
Device problems
- Improper or Incorrect Procedure or Method3
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Clinical Signs, Symptoms or Conditions2
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 16157711 ↗
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-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 · each recall links to the FDA recall notice
- 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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