PowerPICC SOLO2 FT Catheter 3295108FRecalls & reported problems

Bard Access Systems, Inc. · DOT PPICC SOLO FT,5Fr · Class 2 · Implant

All models of PowerPICC SOLO2 FT Catheter (5)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741028069), received between Apr 8, 2021 and May 14, 2025 — classified as 1 injury, 2 malfunctions.

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

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 Leak1
Material Frayed1
Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Cellulitis1
Extravasation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED CATHETER REMOVED DUE TO FISSURE DURING USE. IT WAS LAID ON (B)(6) 2024, REMOVED ON (B)(6) 2025. IT WAS NOT TUNNELED. IT DID NOT HAVE A SUBCUTANEOUS ANCHORING SET (SECURACATH). IT WAS ATTACHED WITH STATLOCK. THE INSERTION POINT IS AT THE ZERO OF THE CATHETERS (THERE WAS NO CATHETER OUTSIDE). ADDITIONAL INFORMATION: PATIENT HAD EXTRAVASATION OF CYTOTOXIC AGENT, THERE WAS EXTENSIVE CELLULITIS IN THE AFFECTED LIMB.
Patient problems: Cellulitis; Extravasation
MAUDE report 22018276 ↗
MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY CUSTOMER THAT STIFFENING STYLET IS BENDING BACK ON ITSELF DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20192981 ↗
MalfunctionApr 8, 2021Material Frayed; Material Frayed
IT WAS REPORTED THE GUIDEWIRE WAS PULLED IT BACK THROUGH THE NEEDLE AS IT WOULD NOT ADVANCE AND IT SHREDDED WHEN PULLED BACK THROUGH THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11633702 ↗

Device details

UDI-DI	`00801741028069`
Brand	PowerPICC SOLO2 FT Catheter
Model	3295108F
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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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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