Midline Catheter Kit S4254108DGRecalls & reported problems
Bard Access Systems, Inc. · 4Fr DL Provena Midline Max Barrier Kit w/GuardIVa · Class 2
All models of Midline Catheter Kit (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741154126), received between May 5, 2025 and May 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Material Deformation1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Material Frayed; Material Frayed
IT WAS REPORTED BY THE CUSTOMER GUIDEWIRE CAME UNRAVELED WHILE INSERTING INTO THE PATIENT. AN ADDITIONAL GUIDEWIRE WAS NEEDED FOR ACCESS CAUSING A DELAY IN THERAPY. COMPLAINANT STATES THERE WAS NO ADVERSE IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962447 ↗MalfunctionMay 5, 2025Defective Component; Material Deformation; Defective Component; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT THE END OF THE GUIDEWIRE IS ROUGH, WOULD NOT ADVANCE THROUGH THE NEEDLE. AN ADDITIONAL GUIDEWIRE WAS NEEDED FOR ACCESS CAUSING A DELAY IN THERAPY. COMPLAINANT STATES THERE WAS NO ADVERSE IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962312 ↗
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 reports
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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