PowerGlide F120081TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 20G 8cm, Full Kit · Class 2
All models of PowerGlide (12)
Data updated Oct 18, 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 00801741142710), received between Jun 11, 2024 and Jun 14, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
Most reported problems
Device problems
- Defective Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT CATHETER SHEERED ON BEVEL OF NEEDLE, GUIDEWIRE WHEN FULLY EXTENDED IS SIGNIFICANTLY BENT. ANOTHER MIDLINE WAS USED, DELAY IN THERAPY. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536915 ↗MalfunctionJun 14, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT CATHETER SHEERED ON BEVEL OF NEEDLE, GUIDEWIRE WHEN FULLY EXTENDED IS SIGNIFICANTLY BENT. ANOTHER MIDLINE WAS USED, DELAY IN THERAPY. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536883 ↗InjuryJun 11, 2024Break; Break
IT WAS REPORTED THAT ROUGHLY 3CM OF CATHETER SHEERED OFF INTO THE PATIENTS VASCULATURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19515554 ↗
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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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