Peripheral Catheter Insertion Kit F220088PTRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20Ga, 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
- 11
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741140624), received between May 21, 2021 and May 12, 2026 — classified as 3 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (4 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
- Material Deformation4
- Break3
- Activation Problem2
- Improper or Incorrect Procedure or Method2
- Defective Component1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Material Deformation
IT WAS REPORTED A DEFECTIVE POWERGLIDE CATHETER WITH ODD CRIMPS/KINKS IN IT, FOUND ON INSERTION. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155994 ↗InjurySep 18, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED ON 9/17/2025: NOTHING WAS FOUND ON X-RAY. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING SITUATION, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT DID UNDERGO A COUPLE OF X-RAYS THAT OTHERWISE WOULD NOT HAVE BEEN EXPOSED TO. IV ANTIBIOTICS WERE TO BE INFUSED. A NEW CATHETER WAS PLACED. THERE WAS NO PATIENT HARM OR NEGATIVE OUTCOME.
Patient problems: Foreign Body In Patient
MAUDE report 23083295 ↗MalfunctionJul 21, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SAFETY DID NOT ACTIVATE ON POWERGLIDE 20/8. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22559527 ↗MalfunctionOct 9, 2024Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH, "I HAD A POWERGLIDE THAT HAD THE 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 (B)(4) PIECE." ADDITIONAL INFO 07/30/2024: PATIENT HAD TO BE STUCK AN ADDITIONAL TIME SINCE THIS PRODUCT MALFUNCTIONED AND INSERTION HAD TO BE ABORTED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH: "INSERTING POWERGLIDE FOR INTRAVENOUS ACCESS. DURING INSERTION, THE HOUSING DEVICE CAME APART AND HAD TO BE PUT BACK TOGETHER. I ADVANCED THE CATHETER AS FAR AS I COULD, UTILIZING THE ULTRASOUND MACHINE, ENGAGED THE GUIDEWIRE AND WAS UNABLE TO ADVANCE THE CATHETER FROM THE DEVICE. I ATTEMPTED TO WITHDRAW THE GUIDEWIRE FROM THE VEIN BUT IT WAS LOCKED IN PLACE. REMOVED ENTIRE POWERGLIDE AS ONE UNIT." 09/12/2024 - THE DEVICE RETURNED FOR EVALUATION EXHIBITED A BEND IN THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409839 ↗InjuryApr 16, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER "NURSE SET UP AND ACCESSED THE VEIN. CLEARLY IN CENTER OF VEIN AND REALIZED THE DEVICE WAS UPSIDE DOWN. PICKED UP PROBE AND FLIPPED IT BACK OVER AND SAW IT WAS STILL IN THE CENTER OF THE VEIN, DEPLOYED THE GUIDEWIRE SMOOTH AS BUTTER, TOOK THE WINGS FORWARD AND GOT HALFLY DOWN, IT STOPPED BUT BUMPED IT AND IT WOULD NOT GO ALL THE WAY AND PULLED OUT WHOLE THE DEVICE BACK. TREY DROPPED A NEW NEEDLE AND WHEN LOOKING AT THE SAME VEIN TO REINSERT A NEW CATHETER REALIZED THAT THERE WAS SOMETHING IN THE VEIN. STOPPED PROCEDURE. PULLED THE CATHETER APART AND REALIZED THE TIP WAS MISSING. PATIENT HAD TO HAVE 2CM OF TIP SURGICALLY REMOVED." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19119013 ↗MalfunctionFeb 15, 2024Defective Component; Defective Component
IT WAS REPORTED BY MEDWATCH THE POWERGLIDE MALFUNCTIONED DURING 1ST ATTEMPT. PINK WINGS WOULD NOT ADVANCED BECAUSE NEEDLE CAME OUT OF CASING. ADDITIONAL INFORMATION 1/31. ¿EVENT HAPPENED ON (B)(6) 2023. I WAS ABLE TO PLACE ANOTHER POWERGLIDE DURING THE SAME VISIT AND THE PATIENT TOLERATED BOTH WELL.¿ THERE ARE NO PHOTOS AND APPEARS THAT THERE IS NO PATIENT IMPACT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712650 ↗InjuryDec 21, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER THAT HE NOTICED BLEEDING IMMEDIATELY AND PULLED BACK ON THE ENTIRE DEVICE. HE SAW THE LIGHTS FROM THE NEEDLE SHINING IN THE ULTRASOUND PICTURE. WHEN HE WITHDREW THE DEVICE, 2 CMS OF THE CATHETER WERE LEFT IN THE PATIENT. THE PATIENT HAD TO GO TO SURGERY TO REMOVE. DEVICE WAS INSERTED INTO THE PATIENT'S RIGHT CEPHALIC AND HIT A WALL.
Patient problems: Foreign Body In Patient
MAUDE report 18379526 ↗MalfunctionNov 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT TUBING SEPARATED FROM THE NEEDLELESS CONNECTOR END AND WOUND-UP CAUSING BLOOD TO REFLUX IN THE LINE AND RENDERED THE LINE UNUSABLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18094299 ↗MalfunctionJul 17, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY CUSTOMER THAT THE CATHETER APPEARED TO BE "CLIPPED" CLOSE TO CATHETER HUB/PROXIMAL LOCATION. WHEN NEEDLE & GUIDEWIRE WAS REMOVED, SCRUB TECH NOTICED IT LOOKED CLIPPED. CATHETER KINKED WHEN HE TRIED TO ADVANCE AND IT WAS ASPIRATING AIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339518 ↗MalfunctionOct 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT POWERGLIDE EXTENSION TUBING KINKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15540384 ↗MalfunctionMay 21, 2021Activation Problem; Activation Problem
IT WAS REPORTED A POWERGLIDE WHERE THE SAFETY MECHANISM THAT IS SUPPOSED TO COVER THE NEEDLE TIP WHEN INSERTED BROKE OFF/DIDN'T ENGAGE WITH INSERTION. WAS THERE ANY PATIENT HARM REPORTED? NO HARM, BUT THE PATIENT HAD TO BE STUCK A SECOND TIME. WHAT THEY'RE BEING TREATED FOR: STROKE. NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864544 ↗
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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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