PowerGlide Pro F322088PTXRecalls & reported problems
Bard Access Systems, Inc. · DOT PG Pro 22G 8cm RT Full B&P w/NG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741152771), received between Mar 5, 2021 and Jul 5, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method3
- Material Frayed2
- Defective Component1
- Difficult to Insert1
- Difficult to Remove1
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.
MalfunctionJul 5, 2023Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT MIDLINE GOT STUCK IN PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 17262820 ↗InjuryJun 22, 2023Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER THAT MIDLINE GOT STUCK IN THE PATIENT. THE SURGEON HAD TO COME AND REMOVE IT. ADDITIONAL INFO RECEIVED ON 15-JUNE-23. SURGERY HAD TO BE CALLED TO REMOVE CATHETER. THE EVENT HAPPENED AT TIME OF PLACEMENT. WHEN INSERTING THE MIDLINE, THE GUIDEWIRE AND CATHETER ADVANCED WITHOUT ANY RESISTANCE BUT UPON TRYING TO RETRACT THE GUIDEWIRE IT WOULD NOT RETRACT. HEAT PACKS WERE APPLIED AND MINIMAL FORCE TO TRY TO PULL ENTIRE MIDLINE OUT WITH NO SUCCESS. IN FEAR OF A PORTION OF THE MIDLINE BREAKING OFF INSIDE THE PATIENT SURGERY WAS CALLED FOR SAFE REMOVAL. COMPLAINANT WAS UNSURE IF THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION. ULTRASOUND WAS USED DURING THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 17183744 ↗MalfunctionJul 23, 2021Material Frayed; Material Frayed
IT WAS REPORTED THE WIRE FELL OFF WHEN ATTEMPTING TO RETRACT BACK INTO THE HOUSING. NO OTHER INFORMATION PROVIDED. ON (B)(6) 2021- THE GUIDEWIRE OF THE RETURNED SAMPLE EXHIBITED A COMPLETE BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12219700 ↗MalfunctionMar 5, 2021Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method
IT WAS REPORTED "CLINICIAN WAS INSERTING POWERGLIDE PRO RT INTO PATIENT; THE NURSE FELT RESISTANCE WHEN ADVANCING THE GUIDEWIRE/CATHETER, AND ATTEMPTED TO REMOVE THE DEVICE. AFTER THE DEVICE WAS ON THE TABLE SHE NOTICED THAT A SMALL PIECE OF GUIDEWIRE AND VERY SMALL PIECE OF CATHETER WAS MISSING, SHEARED OFF INSIDE THE PATIENT." ADD INFO RCVD: 02/09/2021: ARE THERE ANY FRAGMENTS STILL LEFT IN THE PATIENT?: NO DATE OF EXPLANT ? (B)(6) 2021. WHAT THEY¿RE BEING TREATED FOR: BRAIN TUMOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423321 ↗
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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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