PowerGlide F218101TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 18G 10cm, Full Kit wo GIVa · Class 2
All models of PowerGlide (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741142758), received between Jul 23, 2024 and Aug 5, 2026 — classified as 2 injuries, 2 malfunctions.
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
Most reported problems
Device problems
- Break2
- Activation Problem1
- Material Frayed1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Break
It was reported by the customer that Powerglide shearing off the tip yesterday and getting stuck in a patient.Additional information received:It was retained in the tissue per CT scan. It was not removed. They monitored patient for multiple days and patient had no symptoms and the vascular surgery provider recommended no follow up surgery. During insertion, guidewire mechanism was engaged with no resistance but attempt to move midline mechanism forward and halfway in met resistance. Attempted to retract and was met again with resistance. Midline was removed entirely with the retracting resistance. They had done a CT scan that had shown it in patient arm, venogram was done to confirm it was not in the vein. No additional intervention aside from the diagnostic testing post procedure for catheter location. No further details provided.
Patient problems: Foreign Body In Patient
MAUDE report 50144100 ↗MalfunctionSep 23, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS COILED. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23128912 ↗MalfunctionAug 18, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT POWERGLIDE NEEDLE FAILED TO SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834185 ↗InjuryJul 23, 2024Break; Break
IT WAS REPORTED, CATHETER REPORTED TO BE IN AT 4CM, LEFT BASILIC VEIN WITH A BLOOD RETURN. GUIDEWIRE ADVANCED WITHOUT PROBLEMS, ATTEMPTED TO ADVANCE CATHETER, MET RESISTANCE, PULLED THE CATHETER BACK FLUSH. ATTEMPTED TO RETRACT THE GUIDEWIRE AND IT FAILED. PULLED DEVICE BUT ONLY CATHETER AND NEEDLE CAME OUT BUT NO GUIDEWIRE. GUIDEWIRE SHEARING ALONG WITH 3CM OF CATHETER TIP. UPON INSPECTION NOTED ONLY 7CM OF CATHETER REMOVED. NO COLLATERAL BRANCHING OF VESSEL NOTED. GUIDEWIRE CHECKED PRIOR TO PLACEMENT ATTEMPT, NOTHING NOTED TO BE UNUSUAL. X-RAY CONFIRMATION OF GUIDEWIRE IN MID UPPER ARM. REQUIRED SURGICAL INTERVENTION TO REMOVE GUIDEWIRE AND CATHETER TIP FROM BASILIC VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 19807148 ↗
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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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