Midline Catheter KitRecalls & reported problems across all models
Bard Access Systems, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Midline Catheter Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 319
- Deaths reported
- 2
- Injuries reported
- 28
- Recalls
- 3
We found 31 models of Midline Catheter Kit by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 319 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2016 and Sep 2, 2026 — classified as 2 deaths, 28 injuries, 289 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (70 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Midline Catheter Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2026Open, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2667-2026 · Root cause: Nonconforming Material/Component · names 10 of these models · Recall details · FDA record ↗
- May 21, 2026Open, 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 · names 2 of these models · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2662-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗
Most reported Midline Catheter Kit problems
Device problems
- Fluid/Blood Leak70
- Material Deformation65
- Material Frayed40
- Difficult or Delayed Separation29
- Activation Problem26
- Defective Component22
- Break12
- Leak/Splash11
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Consequences Or Impact To Patient58
- No Known Impact Or Consequence To Patient31
- Foreign Body In Patient15
- Pain12
- Needle Stick/Puncture4
- No Patient Involvement3
- Thrombosis/Thrombus3
Midline Catheter Kit models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Midline Catheter Kit P4154108DMidline catheter1 recall1 death126 reports
- Midline Catheter Kit S4153108BDPMidline catheter1 recall36 reports
- Midline Catheter Kit S4153108DMidline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPMidline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPMidline catheter1 recall11 reports
- Midline Catheter Kit P4154108Midline catheter1 recall10 reports
- Midline Catheter Kit S4254108DMidline catheter1 recall8 reports
- Midline Catheter Kit P4254108DMidline catheter1 recall7 reports
- Midline Catheter Kit P4254108Midline catheter1 recall1 death3 reports
- Midline Catheter Kit SP4153108DGMidline catheter1 recall3 reports
- Midline Catheter Kit S4254108DGPMidline catheter1 recall2 reports
- Midline Catheter Kit SP4153108DMidline catheter1 recall2 reports
- Midline Catheter Kit S4153108BPMidline catheter1 recall1 report
- Midline Catheter Kit P4153108DMidline catheter1 recall0 reports
- Midline Catheter Kit S4254108BDMidline catheter1 recall0 reports
- Midline Catheter Kit SP4153108DBMidline catheter23 reports
- Midline Catheter Kit S4153108DGMidline catheter6 reports
- Midline Catheter Kit PP4154108DGPMidline catheter6 reports
- Midline Catheter Kit P4154118Midline catheter5 reports
- Midline Catheter Kit S4153108BDMidline catheter4 reports
- Midline Catheter Kit P4154108DGMidline catheter3 reports
- Midline Catheter Kit S4153108Midline catheter3 reports
- Midline Catheter Kit P4255108DMidline catheter2 reports
- Midline Catheter Kit P4255118Midline catheter2 reports
- Midline Catheter Kit S4254108DGMidline catheter2 reports
- Midline Catheter Kit PP4154108DBPXMidline catheter2 reports
- Midline Catheter Kit P4153108Midline catheter1 report
- Midline Catheter Kit P4255108DGMidline catheter1 report
- Midline Catheter Kit P4153108DGMidline catheter1 report
- Midline Catheter Kit S4254108Midline catheter1 report
- Midline Catheter Kit PP4154108DGPXMidline catheter1 report
Recent Midline Catheter Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572814 ↗MalfunctionAug 12, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220753 ↗MalfunctionAug 11, 2026Difficult or Delayed Separation
It was reported that during placement of a midline catheter, the dilator did not split as intended. One of the pull away tabs broke away from the dilator sheath and the dilator could not be removed as designed.The user obtained a new midline kit, removed the defective component, and successfully placed the midline catheter. No complications or patient injury were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216200 ↗MalfunctionAug 3, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113914 ↗MalfunctionJul 9, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763746 ↗MalfunctionJul 8, 2026Material Deformation
IT WAS REPORTED DURING A TRAINING A SKIN NICK WAS PERFORMED, FOLLOWED BY DIFFICULTY ADVANCING THE DILATOR. WHEN THE DILATOR WAS REMOVED AND INSPECTED, NURSES NOTED THAT IT HAD BUCKLED. EVENT INVOLVED THE 4F DILATOR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749512 ↗MalfunctionJul 1, 2026Material Deformation
IT WAS REPORTED MICROINTRODUCER WAS OBSERVED TO HAVE A DAMAGED SHEATH TIP. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679126 ↗MalfunctionMay 18, 2026Activation Problem
IT WAS REPORTED BY MEDWATCH THAT THE SAFETY FEATURE SLID COMPLETELY OFF THE SHAFT OF THE BD SECURE-LOC INTRODUCER NEEDLE. IT DID NOT LOCK AND STAY IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211620 ↗MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED END OF PICC "FLIPPING" OR "FOLDING BACK" WHEN THREADING, HAD TO SPEND TIME READJUSTING THE LINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162896 ↗MalfunctionApr 28, 2026Material Frayed
IT WAS REPORTED BY CUSTOMER THAT WHILE PLACING A MIDLINE THE INTRODUCER WIRE WOULD NOT ADVANCE PAST THE SHOULDER. WHEN IT WAS RETRACTED THE WIRE WAS LODGED, WHEN MORE PRESSURE WAS APPLIED THE SOFT TIP OF THE WIRE UNRAVELED AND FINALLY RELEASED. THERE WAS CONCERN THAT PART OF THE WIRE MAY HAVE BROKEN OFF AND RETAINED OR MIGRATED CENTRALLY. ADDITIONAL UPPER EXTREMITY X-RAY AND CHEST X-RAY WAS ORDERED TO LOOK FOR ANY RETAINED MATERIALS. NONE WAS NOTED ON THE X-RAY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016700 ↗MalfunctionApr 13, 2026Fluid/Blood Leak
IT WAS REPORTED BY A CUSTOMER THAT THEY ARE EXPERIENCING LEAKING FROM THE POWER MIDLINE. PROCEDURE TOOK PLACE (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865239 ↗MalfunctionApr 1, 2026Fluid/Blood Leak
IT WAS REPORTED CUSTOMER IS EXPERIENCING LEAKING FROM THE POWER MIDLINE. LINE WAS REMOVED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753725 ↗MalfunctionMar 30, 2026Difficult or Delayed Separation
IT WAS REPORTED THAT THE TRIMMABLE MIDLINE KIT INTRODUCERS BREAKING BEFORE REMOVING FROM THE PATIENT. THERE WAS NO HARM, BUT IT WAS A LITTLE DIFFICULT TO GET OUT OF THE PATIENT'S SKIN WITH NOTHING TO PULL WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735652 ↗MalfunctionMar 30, 2026Material Deformation
IT WAS REPORTED THAT 3 FR MIDLINE FAILED WITH THE DILATOR AND WAS SAVED. THE DILATOR PORTION BUNCHED UP ON THE END AND CUSTOMER HAD TO GRAB MST KIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712076 ↗MalfunctionMar 25, 2026Difficult or Delayed Separation
IT WAS REPORTED THAT DURING PLACEMENT OF A 4FR ML CATHETER, THE INTRODUCER MALFUNCTIONED. WHEN BREAKING THE INTRODUCER, ONLY THE LEFT SIDE SEPARATED PROPERLY WHILE THE RIGHT SIDE REMAINED INTACT, LEAVING A TIGHT RING AROUND THE CATHETER. THE CLINICIAN HAD TO CUT THE RING WITH A SCALPEL TO FREE THE CATHETER, THOUGH NO CATHETER DAMAGE OR LEAKAGE WAS OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687824 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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