PowerPICC CK000668Recalls & reported problems

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

All models of PowerPICC (118)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741130847), received between Dec 18, 2019 and Jan 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Deformation2
Difficult or Delayed Separation1

Patient problems

No Consequences Or Impact To Patient2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJan 13, 2026Difficult or Delayed Separation
IT WAS REPORTED THAT ON (B)(6) 2025, THE PICC LINE WAS INSERTED ON A PATIENT. PER THE PICC RN, THE SHEATH DID NOT SPLIT CORRECTLY. THE SHEATH STAYED CONNECTED TO THE CATHETER RESULTING IN A LINE EXCHANGE. THE PATIENT WAS NOT HARMED DUE TO THIS SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24060420 ↗
MalfunctionDec 18, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT INTRODUCERS ARE NOT ADVANCING SMOOTHLY. THEY STATED RESISTANCE TO ADVANCE IS EXPERIENCED, REQUIRING INCREASED PUSHING, THE TIP WHERE THE DILATOR AND SHEATH MEET NOT SMOOTH AND FRAYING AT THE TIP, AND BUCKLING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9491836 ↗
MalfunctionDec 18, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT INTRODUCERS ARE NOT ADVANCING SMOOTHLY. THEY STATED RESISTANCE TO ADVANCE IS EXPERIENCED, REQUIRING INCREASED PUSHING, THE TIP WHERE THE DILATOR AND SHEATH MEET NOT SMOOTH AND FRAYING AT THE TIP, AND BUCKLING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9491834 ↗

Device details

UDI-DI	`00801741130847`
Brand	PowerPICC
Model	CK000668
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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