PowerGlide Midline Catheter M120081Recalls & reported problems
Bard Access Systems, Inc. · DOT PGlide 20G 8cm Full · Class 2
All models of PowerGlide Midline Catheter (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741038068), received between Apr 29, 2016 and May 9, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
- Material Separation1
- Mechanical Jam1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2019Break; Material Separation
IT WAS REPORTED THAT THE J-LOOP BROKE ON HALF WITH PEDIATRIC PATIENT USE. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES LOT # RECS3140.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8595129 ↗MalfunctionApr 29, 2016Fracture; Mechanical Jam
ON (B)(6) 2016- PER SALES REPRESENTATIVE, USER FACILITY REPORTED THAT A RN WAS PLACING A POWERGLIDE. ACCESS WAS ACHIEVED AND THE WIRE DEPLOYED EASILY BUT THEN THE CATHETER MECHANISM SEEMED TO "MALFUNCTION". IT WAS SAID THAT THE CATHETER "JAMMED UP" ON ITSELF AND THE RN COULD NOT REMOVE IT. ANOTHER RN ATTEMPTED TO REMOVE THE DEVICE AND SUCCEEDED. AFTER THE REMOVAL OF THE DEVICE IT APPEARED TO BE FRACTURED. ANOTHER POWERGLIDE WAS SUCCESSFULLY PLACED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5620045 ↗
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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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