Midline Catheter Kit P4255108DGRecalls & reported problems
Bard Access Systems, Inc. · 5Fr DL PowerMidline catheter Max 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741129384), received between Jan 5, 2018 and Jan 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Occlusion Within Device” (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.
Most reported problems
Device problems
- Occlusion Within Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2018Occlusion Within Device
FACILITY REPORTED TO THE SALES REP THAT DURING THE PROCEDURE THE HEALTHCARE PROFESSIONAL WAS UNABLE TO THREAD THE CATHETER AS IT APPEARED TO BE OCCLUDED. THE PROCEDURE WAS STOPPED, DEVICE REMOVED AND A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7170222 ↗
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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