PowerGlide Midline Catheter M118080Recalls & reported problems

Bard Access Systems, Inc. · PowerGlide Midline Catheter 18G, 8cm with Basic Tray · Class 2

All models of PowerGlide Midline Catheter (12)

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

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741038082), received between Feb 24, 2017 and Feb 23, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Break2
Detachment Of Device Component1

Patient problems

Device Embedded In Tissue or Plaque1
Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1
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.

InjuryFeb 23, 2024Break; Break
IT WAS REPORTED, "DURING MIDLINE INSERTION ATTEMPT, THE VEIN WAS ACCESSED. WIRE ADVANCED WITH NO RESISTANCE. CATHETER ADVANCED AND THEN HIT RESISTANCE. CATHETER PULLED BACK. WIRE RETURNED TO CHAMBER AND PULLED CATHETER OUT. UPON REMOVAL OF CATHETER WIRE APPEARED BENT AND HALF OF CATHETER MISSING. XRAY PREFORMED AND CATHETER NOTED TO BE IN ARM." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 18773614 ↗
InjuryJan 16, 2018Break
IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD A MIDLINE PLACED ON (B)(6) 2017. ON (B)(6) 2017 THE MIDLINE BROKE NEAR THE HUB AND THE BROKEN PIECE WAS RETRIEVED. THE RN STATED IT WAS POSSIBLY FROM THE PATIENT RUBBING ON THE BED RAIL, BUT HE WASN'T POSITIVE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7195761 ↗
InjuryFeb 24, 2017Detachment Of Device Component
AS REPORTED BY THE FACILITY, THE WIRE IN THE POWERGLIDE PRO CAME OFF AND HAD TO BE REMOVED FROM THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6356789 ↗

Device details

UDI-DI	`00801741038082`
Brand	PowerGlide Midline Catheter
Model	M118080
Company	Bard Access Systems, Inc.
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Peripheral vascular catheter

A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. 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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