PowerGlide Pro F418108PTRecalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
Data updated Oct 16, 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 00801741232091), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
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.
MalfunctionMay 27, 2026Material Frayed
IT WAS REPORTED BY THE CUSTOMER THAT A SINGLE LUMEN MIDLINE PLACEMENT ATTEMPTED ON RIGHT BASILIC UNDER ULTRASOUND GUIDANCE, NEEDLE INSERTION AND WIRE ADVANCEMENT PERFORMED WITHOUT ISSUES OR RESISTANCE VISUALIZING NEEDLE AND WIRE WITHIN THE VEIN LUMEN, CATHETER ADVANCED ALSO WITHOUT ISSUES, NEEDLE RETRACTED, AND UPON DELIVERY DEVICE RETRIEVAL, PIECE OF WIRE OBSERVED AT THE ENTRANCE OF CATHETER. CATHETER AND WIRE REMOVED AS SINGLE UNIT. BEDSIDE ULTRASOUND DONE WITHOUT GROSS EVIDENCE OF RETAINED WIRE. XRAY DONE ALSO WITHOUT EVIDENCE OF RETAINED FOREIGN BODY. I EXAMINED THE DEVICE AND COMPARED TO A NEW ONE, ON THE EVENT DEVICE PATIENT SIDE TIP OF WIRE INTACT, WIRE APPEARS TO HAVE BROKEN AT END THAT SECURES TO DELIVERY DEVICE/NEEDLE, WITH REMAINING PIECE LIKELY WITHIN DEVICE ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301809 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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