PowerGlide Pro F320108PTXRecalls & reported problems
Bard Access Systems, Inc. · DOT PG Pro 20G10cm RT Full B&P w/NG · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741152764), received between Jan 26, 2023 and Jul 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CATHETER HAD A PERFORATION BETWEEN THE JUNCTION OF THE CATHETER HUB AND THE START OF THE CATHETER. IT HAD TO BE PULLED OUT OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19672348 ↗InjuryJan 26, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER, "I STUCK THE PATIENT FOLLOWED IT ON ULTRASOUND UNTI I WAS IN THE MIDDLE, INSERTED THE WIRE NO ISSUES THEN THE CATHETER HAD RESISTANCE SO I WENT TO REMOVE HAD RESISTANCE SO ANOTHER NURSE TRIED AND THAT IS WHEN WE REALIZED THE CATHETER HAD BROKE OFF. PATIENT HAD TO GO TO IR TO RETRIEVE THE CATHETER."
Patient problems: Foreign Body In Patient
MAUDE report 16250236 ↗
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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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