PowerPICC CK000293Recalls & reported problems

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

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: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741038020), received between Feb 27, 2024 and Apr 10, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Recalls naming this device

May 21, 2026Open, 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 · FDA record ↗

Most reported problems

Device problems

Material Deformation1

Patient problems

Failure of Implant1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionApr 10, 2024Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH A NURSE ATTEMPTED TO PLACE A PERIPHERALLY INSERTED CENTRAL CATHETER LINE IN THE PATIENT'S LEFT UPPER EXTREMITY. WHEN TRYING TO ADVANCE THE PERIPHERALLY INSERTED CENTRAL CATHETER TO THE SUPERIOR VENA CAVA, THE PERIPHERALLY INSERTED CENTRAL CATHETER COILED. THE NURSE WAS NOT ABLE TO RETRACT THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE. AN X-RAY OF THE LEFT UPPER EXTREMITY SHOWED THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE WAS KNOTTED. THE PATIENT WAS TAKEN TO THE OPERATION ROOM FOR PERIPHERALLY INSERTED CENTRAL CATHETER LINE REMOVAL. LOT#: REHU189B.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082369 ↗
InjuryFeb 27, 2024
A NURSE ATTEMPTED TO PLACE A PERIPHERALLY INSERTED CENTRAL CATHETER LINE IN THE PATIENT'S LEFT UPPER EXTREMITY. WHEN TRYING TO ADVANCE THE PERIPHERALLY INSERTED CENTRAL CATHETER TO THE SUPERIOR VENA CAVA, THE PERIPHERALLY INSERTED CENTRAL CATHETER COILED. THE NURSE WAS NOT ABLE TO RETRACT THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE. AN X-RAY OF THE LEFT UPPER EXTREMITY SHOWED THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE WAS KNOTTED. THE PATIENT WAS TAKEN TO THE OPERATION ROOM FOR PERIPHERALLY INSERTED CENTRAL CATHETER LINE REMOVAL.
Patient problems: Failure of Implant
MAUDE report 18797669 ↗

Device details

UDI-DI	`00801741038020`
Brand	PowerPICC
Model	CK000293
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.