Midline Catheter Kit P4254108DRecalls & reported problems
Bard Access Systems, Inc. · 4Fr 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741129353), received between Jun 9, 2017 and Jul 26, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 21, 2026Class IIOpen, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2663-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak3
- Break1
- Component Incompatible1
- Hole In Material1
- Leak/Splash1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2024Component Incompatible; Component Incompatible
IT WAS REPORTED TRYING TO PUT IN MIDLINE BUT NURSE UNABLE TO SEPARATE THE LINE AND NEEDLE. UNKNOWN IF PATIENT WAS HARMED. THERE WAS PATIENT IMPACT, MIDLINE COULD NOT BE INSERTED AND PROCEDURE WAS CANCELLED. THE PROBLEM OCCURRED WITH THE FLEXIBLE END OF THE GUIDEWIRE, IT GOT CAUGHT ON THE END OF THE INSERTION NEEDLE BEVEL AND COULD NOT BE REMOVED OR ADVANCED. NO OTHER INFORMATION WAS PROVIDED. 07/03/2024 - THE GUIDEWIRE RETURNED FOR EVALUATION EXHIBITED A KINK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19837644 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE MIDLINE ¿LEAKED FROM AROUND INSERTION SITE¿.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985739 ↗MalfunctionApr 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MIDLINE CATHETER WAS ¿LEAKING AT SITE¿.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9985735 ↗MalfunctionMar 20, 2019Leak/Splash
IT WAS REPORTED MIDLINE WAS SPILT AT SUTURE WING AND WAS LEAKING. THE MIDLINE WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8437276 ↗InjurySep 7, 2018Break; Material Fragmentation
IT WAS REPORTED THAT DURING THE INSERTION PROCEDURE WHEN THE PROVIDER WAS REMOVING THE GUIDEWIRE, IT BROKE AND A SEGMENT OF THE GUIDEWIRE REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7856061 ↗MalfunctionAug 31, 2017Hole In Material
FACILITY REPORTED TO THE SALES REP THAT SMALL HOLES WERE FOUND ON EITHER SIDE OF THE MICROINTRODUCER THAT ALLOWED BLOOD TO COME OUT EVENT WHILE THE END CAP WAS ON. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6836708 ↗MalfunctionJun 9, 2017Fluid/Blood Leak
PER SALES REP, THE FACILITY REPORTED THAT A DUAL LUMEN MIDLINE LEAKED AT THE CONNECTION OF BIFURCATION AND CATHETER. THE CATHETER WAS REMOVED. THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6632417 ↗
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 · each recall links to the FDA recall notice
- 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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