Peripheral Catheter Insertion Kit F218088PTRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 18Ga, 8cm · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741140600), received between Oct 29, 2020 and Oct 15, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Defective Component1
- Difficult to Insert1
- Material Twisted/Bent1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Sore Throat1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Activation Problem; Activation Problem
IT WAS REPORTED POWERGLIDE WAS PLACED SUCCESSFULLY, WHEN PULLING THE NEEDLE OUT THE SAFETY MALFUNCTIONED AND DID NOT ACTIVATE WHEN THE NEEDLE WAS PULLED OUT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285443 ↗MalfunctionFeb 24, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED BY THE CUSTOMER, "POWERGLIDE GUIDEWIRE STICK AFTER IT WAS ENGAGED. I FOLLOWED THE NEEDLE TIP ALL THE WAY IN. THE NEEDLE ENCASEMENT DID COME APART DURING INSERTION. I ENGAGED THE GUIDEWIRE WITHOUT DIFFICULTY. I ATTEMPTED TO ADVANCE THE CATHETER AND IT WOULD NOT MOVE AT ALL. I THEN ATTEMPTED TO PULL THE GUIDEWIRE BACK IN AND IT WOULD NOT MOVE. I REMOVED THE UNIT AS 1 PIECE." ADDITIONAL INFORMATION 7/30/2025: IT WAS REPORTED THE PATIENT HAD TO BE STUCK AN ADDITIONAL TIME. 1/27/2025 - DURING EVALUATION OF THE RETURNED DEVICE, THE GUIDEWIRE WAS FOUND TO HAVE MISALIGNED COILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21453077 ↗MalfunctionSep 13, 2024Defective Component; Defective Component
IT WAS REPORTED VIA MEDWATCH THAT UNABLE TO DEPLOY THE CATHETER OVER THE GUIDEWIRE OR TO RETRACT THE GUIDEWIRE. DURING THE INSERTION THE HOUSING DEVICE CAME APART AND HAD TO BE PUT BACK TOGETHER. THE GUIDEWIRE WAS DEPLOYED BUT UNABLE TO DEPLOY THE CATHETER OVER THE GUIDEWIRE OR TO RETRACT THE GUIDEWIRE. THE DEVICE WAS REMOVED AS AN ENTIRE UNIT FROM THE PATIENT'S ARM AND ANOTHER DEVICE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20214520 ↗MalfunctionAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY CUSTOMER THAT NURSE INSERTED POWERGLIDE USING OUR MASK IN THE KIT AND GOT NASAL AND THROAT IRRITATION. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: Sore Throat
MAUDE report 20049039 ↗InjuryFeb 20, 2024Break; Break
IT WAS REPORTED BY CUSTOMER, "MIDLINE WAS NOTICED TO BE BROKEN OFF AT THE INSERTION SITE. THE PATIENT REQUIRED X-RAYS TO CONFIRM THE SITE OF RETAINED CATHETER FRAGMENTS AND SURGICALLY REMOVED. FRAGMENTS MEASURED 9CM." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18740151 ↗MalfunctionOct 29, 2020Material Twisted/Bent; Positioning Problem
IT WAS REPORTED "NURSE WAS ATTEMPTING TO PLACE THE LINE AND WAS NOT SUCCESSFUL SO ANOTHER NURSE STEPPED IN AND PLACED IT. ONCE THEY REMOVED THE HOUSING CHAMBER FROM THE CATHETER THEY NOTICED THE WIRE WAS NOT STICKING OUT. MULTIPLE XRAYS AND A CHEST CT WERE DONE WITH NO EVIDENCE OF A RADIOPAQUE FOREIGN OBJECT SEEN. AFTER LOOKING CLOSER IT APPEARS THE WIRE IS LOOPED AT THE BACK END OF THE HOUSING CHAMBER."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10759436 ↗
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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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