PowerGlide F118101DTRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 18G 10cm, Max Barrier Kit · Class 2
All models of PowerGlide (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741142802), received between Nov 30, 2023 and Nov 30, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY CUSTOMER THAT POWERGLIDE GUIDEWIRE "DID NOT FUNCTION" CORRECTLY. REP MENTIONED IT LOOKS LIKE THE SAMPLE HAS THE GUIDEWIRE DEPLOYED BUT BENT, WITH THE CATHETER DEPLOYED AS WELL. ADDITIONAL INFORMATION RECEIVED 07-05-2023: IT WAS REPORTED BY THE CUSTOMER A SECOND UNIT WAS PLACED WITH NO EVENT. DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. 11/9/2023 - ONE DEVICE WAS RETURNED FOR EVALUATION AND THE GUIDEWIRE WAS FOUND TO HAVE DISJOINTED COILS AND SHARP BENDS ON THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18238612 ↗
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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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