Midline Catheter Kit PP4154108DBPXRecalls & reported problems
Bard Access Systems, Inc. · DOT 4FSL PWERML MBP W/BIOP PC NG · 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 00801741185205), received between May 12, 2023 and Nov 12, 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
- Difficult or Delayed Separation1
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.
MalfunctionNov 12, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED CUSTOMER HAS BEEN HAVING TROUBLE WITH THE PEEL AWAY SHEATHES IN OUR KITS. THEY ARE ALL OF A SUDDEN VERY HARD TO BREAK APART - WE HAVE NOT NOTICED THIS ISSUE UNTIL ABOUT A MONTH AGO. WE HAVE HAD THE TROUBLE WITH THE POWERMIDLINE KITS WITHOUT THE CHG GEL DRESSINGS. NO FURTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533008 ↗MalfunctionMay 12, 2023Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER "NOTICED LEAK IN EXTENSION SET NEAR T-LOCK EXTENSION SET OF MIDLINE CATHETER WHEN FLUSHING SALINE PRIOR TO STARTING MIDLINE INSERTION PROCEDURE. STOPPED PROCEDURE AND WENT TO GET A NEW MIDLINE. DID NOT USE KIT WITH LEAK NOTED IN EXTENSION. NO HARM REPORTED; SAFETY CONCERN FOR CLINICIAN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924482 ↗
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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