PowerGlide F118080TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 18G 8cm, Basic Kit · Class 2
All models of PowerGlide (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741142642), received between Sep 29, 2022 and Oct 15, 2025 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation3
- Material Frayed3
- Detachment of Device or Device Component2
- Break1
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- Hematoma1
- Infiltration into Tissue1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Material Frayed; Material Frayed
ADDITIONAL INFORMATION: WE HAD TO REDO THE CATHETER INSERTION WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS FOR THE PATIENT, OTHER THAN A SECOND PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292307 ↗InjuryMar 11, 2025Break; Break
IT WAS REPORTED VIA MEDWATCH "NURSE AT PATIENT BEDSIDE TO REMOVE MIDLINE IV DUE TO LEAKING. WHEN THE NURSE ATTEMPTED TO REMOVE THE MIDLINE, THE CATHETER BROKE AT THE HUB LEAVING PART OF THE CATHETER IN THE PATIENT'S ARM. INTERVENTION REQUIRED TO REMOVE REMAINING CATHETER."
Patient problems: Foreign Body In Patient
MAUDE report 21574471 ↗MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A MIDLINE BROKE AND INFILTRATED IN THE PATIENT ARM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Infiltration into Tissue
MAUDE report 20924903 ↗MalfunctionDec 11, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A MIDLINE JUST INFILTRATED IN THE PATIENT ARM AND THE GUIDEWIRE DISINTEGRATED IN THE PATIENT ARM WHEN WE WERE ADVANCING IT AND IT CAUSED A BIG HEMATOMA ON OUR PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Hematoma
MAUDE report 20907085 ↗MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "UPON PULLING BACK ON DEVICE HOUSING TO SAFETY WITH RIGHT HAND WHILE HOLDING WINGS STEADY WITH LEFT HAND THE NEEDLE SEPARATED FROM THE HOUSING." THERE WAS NO IMPACT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2023 - SIXTEEN SAMPLES WERE RETURNED FOR EVALUATION. THE NEEDLE DETACHED EASILY FROM THE HOUSING ON TWO OF THE RETURNED SAMPLES. THIS REPORT ADDRESSES THE SECOND SAMPLE WITH AN EASILY DETACHED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17968422 ↗MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "UPON PULLING BACK ON DEVICE HOUSING TO SAFETY WITH RIGHT HAND WHILE HOLDING WINGS STEADY WITH LEFT HAND THE NEEDLE SEPARATED FROM THE HOUSING." THERE WAS NO IMPACT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. ON 10/13/2023, SIXTEEN SAMPLES WERE RETURNED FOR EVALUATION. THE NEEDLE DETACHED EASILY FROM THE HOUSING ON TWO OF THE RETURNED SAMPLES. THIS REPORT ADDRESSES THE FIRST SAMPLE WITH AN EASILY DETACHED NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16613131 ↗MalfunctionFeb 8, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER ISSUES WITH 2 MIDLINE CATHETERS KINKING IN THE VESSEL UPON INSERTION. SONOSITE GUIDANCE WAS USED AND THE SURGEON WAS PRESENT. IT WAS STATED THERE WAS NO PATIENT OR USER IMPACT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Insufficient Information
MAUDE report 16318668 ↗MalfunctionFeb 8, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER ISSUES WITH 2 MIDLINE CATHETERS KINKING IN THE VESSEL UPON INSERTION. SONOSITE GUIDANCE WAS USED AND THE SURGEON WAS PRESENT. IT WAS STATED THERE WAS NO PATIENT OR USER IMPACT. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Insufficient Information
MAUDE report 16318627 ↗MalfunctionFeb 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER, HAVING ISSUES WITH MIDLINE CATHETERS KINKING IN THE VESSEL UPON INSERTION. SONOSITE GUIDANCE WAS USED, AND THE SURGEON WAS PRESENT.
Patient problems: Insufficient Information
MAUDE report 16296339 ↗InjurySep 29, 2022Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method
IT WAS REPORTED VIA MEDWATCH "DURING A MIDLINE CATHETER PLACEMENT, THE VEIN WAS ACCESSED, HOWEVER, THE CATHETER WAS UNABLE TO BE SUCCESSFULLY THREADED OVER THE DEVICE'S GUIDE WIRE. THE PROCEDURE WAS STOPPED AND THE DEVICE WAS WITHDRAWN. UPON REMOVAL AND INSPECTION OF THE MIDLINE DEVICE, THE GUIDEWIRE WAS NOT PRESENT OR ATTACHED TO THE DEVICE. X-RAY OBTAINED AND REVEALED THE PRESENCE OF FOREIGN BODY TO THE LEFT LOWER CALF. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FOREIGN BODY REMOVAL." ADDITIONAL INFORMATION RECEIVED 09/27/2022: WERE ALL THE MISSING PIECES RETRIEVED AND ACCOUNTED FOR? YES.
Patient problems: Foreign Body In Patient
MAUDE report 15505333 ↗
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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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