HydroPICC Catheter PICC-142CMRecalls & reported problems

Access Vascular, Inc. · 4Fr Single Lumen Marked Peripherally Inserted Central Catheter (PICC) · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850030354372), received between Aug 15, 2025 and Sep 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak2

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE WAS CONTACTED BY A CUSTOMER TO STATE THAT AN INSERTED CATHETER WAS LEAKING INFUSATE. THE CUSTOMER REPORTED THAT THE CATHETER WAS INSERTED (B)(6) 2025. A VIDEO TAKEN BY THE CUSTOMER SHOWED A LEAK AT THE 5CM MARK. THE CATHETER WAS REMOVED WITH NO FURTHER CONSEQUENCES TO THE PATIENT. THE CUSTOMER REPORTED THAT THE CATHETER WAS DISCARDED UPON REMOVAL.
Patient problems: Insufficient Information
MAUDE report 23085749 ↗
MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
REPORT OF A HOLE IN THE CATHETER.
Patient problems: Insufficient Information
MAUDE report 22815628 ↗

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, Classified
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Z-1130-2023 · Dec 16, 2022 · Open, Classified
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Z-1131-2023 · Dec 16, 2022 · Open, Classified
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Z-0199-2023 · Feb 24, 2021 · Terminated
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Device details

UDI-DI	`00850030354372`
Brand	HydroPICC Catheter
Model	PICC-142CM
Company	Access Vascular, Inc.
Product code	LJS · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Class	Class 2
FDA submission	K193015
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 8, 2024

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Other Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days devices

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Groshong NXT ClearVue Catheter 7655405
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2 deaths1,536 reports
PowerPICC Catheter 3174118
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L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cm
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2 recalls245 reports
PowerPICC SOLO2 Catheter 1194108D
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2 recalls216 reports
Broviac 0600520
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
1 recall265 reports
Groshong® Catheter 7717405
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
279 reports
PowerPICC Catheter 3275118
Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days
272 reports

All Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days devices →

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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