Midline Catheter Kit P4255108DRecalls & reported problems
Bard Access Systems, Inc. · 5Fr DL PowerMidline catheter Max Kit · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741129360), received between Jan 3, 2024 and Mar 7, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult or Delayed Separation1
- Material Deformation1
Patient problems
- Foreign Body Embolism1
- 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.
InjuryMar 7, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT REQUIRED A MIDLINE IV TO BE PLACED BY A QUALIFIED INTERVENTIONAL RADIOLOGY REGISTERED NURSE, WHICH REPORTED TO HAVE BEEN INSERTED WITH NO ISSUES. THE PATIENT¿S CONDITION DECOMPENSATED, AND SHE REQUIRED AN INTENSIVE CARE CONSULT WITH ADDITIONAL OXYGEN NEED AND VASOPRESSORS. A CT (COMPUTERIZED TOMOGRAPHY) OF THE CHEST/ABDOMEN/PELVIS WITHOUT CONTRAST WAS ORDERED. IN THE READING, THERE WAS NOTED TO BE A NEW \LINEAR METALLIC DENSITY WITHIN THE RIGHT AND LEFT PULMONARY ARTERIES, FAVORED TO REPRESENT A FOREIGN BODY SUCH AS A CATHETER OR GUIDEWIRE FRAGMENT¿. A CT PERFORMED 3 DAYS PRIOR TO THE MIDLINE INSERTION DID NOT SHOW THE FOREIGN BODY. ADDITIONAL INFORMATION RECEIVED 03/01/2024: IT WAS REPORTED THE FOREIGN MATERIAL WAS NEVER REMOVED PRIOR TO EXPIRATION. WE CANNOT CONFIRM IT HAD AN EFFECT ON THE OUTCOME, ONLY THAT IT WAS IDENTIFIED ON IMAGING.
Patient problems: Foreign Body Embolism; Foreign Body In Patient
MAUDE report 18856495 ↗MalfunctionJan 3, 2024Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation
IT WAS REPORTED BY THE CUSTOMER THAT PICC KIT HAD DIFFICULTY TEARING AND SEPARATING. HAVING TO MANIPULATE PICC SITE LEADING TO INCREASED TOUCHES AND RISK FOR INFECTION. INABILITY TO PLACE LINE IS POSSIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18441132 ↗
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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