PowerPICC SOLO CK000586BRecalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

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

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741212789), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 FDA recall records name this device's identifier, 2 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

May 21, 2026Class IIOpen, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
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

Contamination /Decontamination Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED PLACED A POWERPICC SOLO ON (B)(6) AND IT FLUSHED FINE. ON (B)(6) THE LINE FELT OCCLUDED, THEY ADMINISTERED TPA AND IT STILL WAS OCCLUDED, THEY THEN NOTICED A PIECE OF CATHETER MATERIAL IN THE LUMEN OF THE PICC LINE. THEY TOOK THE LINE OUT OF THE PATIENT AND CUT THE LUMEN TO EXAMINE THE PIECE OF PURPLE CATHETER STUCK IN IT. PATIENT NEEDED NEW LINE PLACED AND DELAY IN CARE DUE TO NOT BEING ABLE TO USE THIS LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851489 ↗

Device details

UDI-DI	`00801741212789`
Brand	PowerPICC SOLO
Model	CK000586B
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 · 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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