PowerGlide F118101TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 18G 10cm, Full Kit · 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 00801741142703), received between Jun 24, 2022 and May 23, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem2
- Break1
- 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.
MalfunctionMay 23, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT A POWERGLIDE THAT HAD A SAFETY MALFUNCTION. NO ADVERSE EVENT REPORTED. NO OTHER INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383747 ↗InjuryMar 21, 2024Material Frayed; Material Frayed
IT WAS REPORTED BY THE CUSTOMER THE WIRE OF THE POWERGLIDE FRAYED AND A PIECE WAS LEFT IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18950364 ↗MalfunctionSep 18, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT CUSTOMER PLACED A MIDLINE IN A PATIENT USING AN AST POWERGLIDE. UPON THE CATHETER LAUNCHING FROM THE NEEDLE CUSTOMER NOTICED IMMEDIATELY THAT THE NEEDLE SAFETY DID NOT DEPLOY. THEREFORE, CUSTOMER HAD AN UNPROTECTED AND EXPOSED NEEDLE AFTER PERFORMING THE PROCEDURE. CUSTOMER PLACED THE UNIT IN AN EMPTY SHARPS CONTAINER IMMEDIATELY FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17769542 ↗InjuryJun 24, 2022Break; Break
IT WAS REPORTED VIA MEDWATCH "THE VASCULAR ACCESS TEAM NURSE ATTEMPTED INSERTION UNDER ULTRASOUND GUIDANCE OF A POWER GLIDE PRO CATHETER IN THE PATIENT'S RIGHT UPPER ARM CEPHALIC VEIN. THE VEIN WAS ACCESSED WITH A NEEDLE AND GOOD BLOOD RETURN WAS OBTAINED. THE GUIDEWIRE WAS ADVANCED WITHOUT INITIAL RESISTANCE, BUT MET RESISTANCE WHILE ADVANCING THE CATHETER. THE NURSE STOPPED THE ATTEMPT TO ADVANCE, BUT HIS WAS INEFFECTIVE. THE DEVICE WAS REMOVED FROM THE PATIENT WHILE EXTENDING THE CATHETER TO SHIELD THE NEEDLE AS THE DEVICE WAS WITHDRAWN. UPON INSPECTION, THE CATHETER APPEARED TO BE INTACT. THE ENTIRE DEVICE WAS DEPOSITED IN SHARPS CONTAINER IN THE PATIENT'S ROOM. A REPEAT ULTRASOUND ASSESSMENT WAS PERFORMED AND FOUND VESSEL DIFFICULT TO VISUALIZE AND AN ABNORMAL APPEARANCE SUSPICIOUS FOR FOREIGN OBJECT RETENTION. PATIENT REPORTED NO DISCOMFORT IN THE AFFECTED AREA. OVERALL PATIENT CONDITION WAS UNCHANGED. IMMEDIATELY REPORTED MY FINDINGS AND CONCERNS TO THE INTENSIVIST WHO ORDERED A FOLLOW UP ULTRASOUND PF THE AFFECTED AREA. THE US (ULTRASOUND) OF THE RIGHT UPPER EXTREMITY REVEALED A THROMBOSIS OF THE CEPHALIC VEIN ON THE RIGHT SIDE IN THE ARM AND A 3CM SEGMENT OF THE CATHETER W
Patient problems: Foreign Body In Patient
MAUDE report 14804544 ↗
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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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