PowerPICC SOLO CK000409Recalls & reported problems

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

Data updated Oct 16, 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 00801741096280), received between Feb 28, 2019 and Feb 25, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Device problems

Device Dislodged or Dislocated1
Leak/Splash1
Material Fragmentation1
Therapeutic or Diagnostic Output Failure1

Patient problems

Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionFeb 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED "PICC PLACE 12/23 CK000409A 4 FRENCH DUAL LUMEN POWERPICC PROVENA SOLO, LOT REEV1496 OUT 0 CM. DRESSING CHANGE 12/30 NO DOCUMENTATION OF EXTERNAL LENGTH. DRESSING CHANGE AGAIN 12/31 AND IT WAS OUT 3 CM. ISSUES PRESENTED LATER THAT DAY. NO PRODUCT AVAILABLE FOR RETURN."
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11379777 ↗
MalfunctionMar 13, 2019Leak/Splash
IT WAS REPORTED THAT PICC LINE WAS INSERTED, RN WENT TO FLUSH THE RED LUMEN AND NOTICED LEAKING FROM THE HUB. PICC WAS REMOVED DUE TO THE LEAKING AND A NEW ONE WAS PLACED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8416533 ↗
InjuryFeb 28, 2019Material Fragmentation
IT WAS REPORTED VIA MEDWATCH "PICC LINE PLACED BY PICC TEAM WITH NO NOTED COMPLICATIONS. METALLIC STRUCTURE SEEN ON CXR AFTER PLACEMENT OF PICC, FIRST NOTED BY RADIOLOGY. WAS NOTED TO BE SUSPICIOUS FOR RETAINED GUIDEWIRE FRAGMENT T L PERIHILAR REGION ON RADIOLOGY READ OF CXR. RADIOLOGY DID CALL CTS TEAM AND MAKE AWARE OF FOREIGN BODY. AFTER DISCUSSION WITH ATTENDING, PT UNDERWENT IR REMOVAL OF APPROX. 6 CM METALLIC WIRE IN L PA WITH NO COMPLICATIONS. PT HAS BEEN STABLE SINCE REMOVAL AND WAS MONITORED AFTERWARDS WITH CXR/LABS".
Patient problems: Foreign Body In Patient
MAUDE report 8380136 ↗

Device details

UDI-DI	`00801741096280`
Brand	PowerPICC SOLO
Model	CK000409
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
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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