PowerPICC SOLO2 Catheter 3194108Recalls & reported problems

Bard Access Systems, Inc. · DOT PowerPICC, Solo, · Class 2 · Implant

All models of PowerPICC SOLO2 Catheter (20)

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: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741027710), received between Aug 9, 2024 and Nov 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

Mar 11, 2025Class IOpen, Classified
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak1
Material Frayed1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionNov 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON (B)(6) 2024 I PLACED A POWERPICC SOLO CATHETER. ON (B)(6) 2024 I WAS CALLED TO THE INFUSION DEPARTMENT BECAUSE THE PICC LINE WAS LEAKING. I TOOK THE DRESSING OFF AND PULLED THE PICC AS I FLUSHED IT AND FOUND 2 CRACKS IN THE PICC ABOUT 5CM UP FROM THE HUB. THE PATIENT SAID HIS ARM FELT FULL AFTER HIS LAST INFUSION. THE PICC LINE WAS REMOVED AND I PLACED A 2.25 MIDLINE IN THE PATIENT SO HE COULD RECEIVE HIS TREATMENT. THE FOLLOWING DAY I PLACED ANOTHER PICC LINE IN THE OPPOSITE ARM. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20708902 ↗
MalfunctionAug 9, 2024Material Frayed; Material Frayed
IT WAS REPORTED, THE STYLET BROKE WHEN THEY REMOVED IT FROM THE PATIENT DUE TO AN UNSUCCESSFUL PLACEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19954130 ↗

Device details

UDI-DI	`00801741027710`
Brand	PowerPICC SOLO2 Catheter
Model	3194108
Company	Bard Access Systems, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2021

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.

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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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