PowerLine 0730610Recalls & reported problems

Bard Access Systems, Inc. · PowerLine Central Venous Catheter. 6F Triple-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff. Intermediate Kit · Class 2 · Implant

All models of PowerLine (6)

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

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741036620), received between Dec 7, 2018 and Dec 26, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 18, 2026.

Most reported problems

Device problems

Fluid/Blood Leak6
Material Puncture/Hole5
Fracture1
Loss of or Failure to Bond1

Patient problems

No Clinical Signs, Symptoms or Conditions6
No Consequences Or Impact To Patient1
Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT TWO MONTHS TWENTY FOUR DAYS POST CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY DETACHED AND REMAINED INSIDE THE PATIENT FOLLOWING THE DEVICE CATHETER REMOVAL PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16046676 ↗
InjuryNov 29, 2022Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 15876137 ↗
MalfunctionNov 29, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876132 ↗
MalfunctionNov 29, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT SOMETIME POST A CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK AND HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876131 ↗
MalfunctionNov 29, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876097 ↗
MalfunctionNov 29, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT SOMETIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15876081 ↗
MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A HOLE WAS ALLEGEDLY DISCOVERED IN THE CHRONIC CATHETER THAT CAUSED A LEAK. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REPLACED THE NEXT DAY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8144323 ↗

Device details

UDI-DI	`00801741036620`
Brand	PowerLine
Model	0730610
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	Aug 28, 2024

Device type (GMDN): Centrally-inserted central venous catheter

A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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