Midline Catheter Kit S4153108BDPRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741154003), received between Feb 12, 2020 and Aug 3, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (16 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.

Recalls naming this device

1. 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-2667-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50113914 ↗
• InjuryFeb 11, 2026Difficult to Remove

  IT WAS REPORTED BY CUSTOMER THAT WHEN THEY WENT IN TO HAVE THE MIDLINE REMOVED, THE NURSE HAD DIFFICULTY REMOVING IT AND HAD TO GO TO THE ER AND HAVE IT SURGICALLY REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Anxiety; Discomfort

  MAUDE report 24316517 ↗
• MalfunctionJan 23, 2026Material Deformation

  IT WAS REPORTED THAT THE PROVENA MIDLINE 3FR INTRODUCER GREY PLASTIC PIECE WAS WARPED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162779 ↗
• MalfunctionSep 11, 2025Defective Component; Defective Component

  IT WAS REPORTED PLACING A MIDLINE ON (B)(6) 2025, WHILE PUSHING THE GUIDEWIRE DOWN, IT SUDDENLY STOPPED AFTER BEING SEVERAL CM PAST THE TIP OF THE NEEDLE. WHEN I WENT TO PULL IT OUT TO READJUST, I FOUND THAT I COULDN¿T. THE GUIDEWIRE WAS STUCK IN THE NEEDLE. USING THE ULTRASOUND, I SAW NOTHING UNUSUAL. I REMOVED BOTH THE NEEDLE AND GUIDEWIRE AT THE SAME TIME AND WENT AHEAD WITH MY SECOND ATTEMPT, USING A SEPARATE NEEDLE AND GUIDEWIRE. I HAD NO ISSUES ON MY SECOND ATTEMPT. AFTER THE PROCEDURE WAS COMPLETED, I NOTED A SMALL BURR ON THE GUIDEWIRE WHERE IT HAD CAUGHT ON THE NEEDLE. THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025385 ↗
• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN THAT PICC LINE WAS LEAKING AT SITE. WHEN FLUSHING OR CONNECTING TO THE WHITE LUMEN ONLY, FLUID/BLOOD WOULD ESCAPE AT INSERTION SITE. RECOMMENDED REMOVAL OF LINE AND LINE HOLIDAY. LINE WAS REMOVED PER MD ORDER AND AT THE 6CM MARK, NOTED THAT THERE WERE APPROXIMATELY 4 SMALL HOLES IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683394 ↗
• MalfunctionJul 3, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT ONE SIDE OF THE 3F PROVENA MIDLINE INTRODUCER BROKE OFF WHILE IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398615 ↗
• MalfunctionSep 20, 2024Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO ADVANCE GUIDEWIRE, RESISTANCE WAS MET. GUIDEWIRE WITHDRAWN AND REPOSITIONING OF NEEDLE VIA ULTRASOUND ATTEMPTED MULTIPLE TIMES WITH UNSUCCESSFUL WIRE ADVANCEMENT. THEN WIRE COULD NOT BE REMOVED FROM PATIENT ARM, EVEN AFTER REMOVAL OF NEEDLE. GUIDEWIRE APPEARED TO HAVE FOLDED OVER ITSELF AND CREATED A ¿KNOT¿. NO IMPACT TO PATIENT, GUIDEWIRE SUCCESSFULLY REMOVED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272691 ↗
• MalfunctionSep 6, 2024Activation Problem; Activation Problem

  IT WAS REPORTED PLACING MIDLINE AT FACILITY. FINISHED ACCESSING VESSEL AND NEEDLE DIDN'T SAFETY, POSSIBLE NEEDLE STICK TO CLINICIAN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162619 ↗
• MalfunctionJul 18, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED VIA MEDWATCH THAT DURING INSERTION OF A 3FR POLYMIDLINE, ONE HALF OF THE HUB OF THE PEEL-AWAY SHEATH POPPED OFF OF THE ALREADY SPLIT BODY OF THE SHEATH WHILE IT WAS STILL IN THE PATIENT. THE CLINICIAN WAS ABLE TO GRASP THE END WITH MY FINGERS AND REMOVE IT ENTIRELY FROM THE PATIENT'S ARM. THE HUB AND THE BODY ARE NOT SUPPOSED TO SEPARATE FROM EACH OTHER AT ANY TIME DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344130 ↗
• MalfunctionJul 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT WIRE SHEARED WHEN REMOVED FROM PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17313290 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, PLACED A MIDLINE AND IT WAS LEAKING THIS MORNING, SO IT WAS REPLACED. AFTER PULLING THE LINE THIS MORNING, SHE FLUSHED IT AND IT SEEMED TO BE WORKING WITH NO LEAKING THROUGHOUT THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791120 ↗
• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT WHEN PLACED A MIDLINE ON 2/9 AND IT STARTED LEAKING AND NEEDED REPLACEMENT ON 2/17. THE CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773039 ↗
• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT A MIDLINE WAS PLACED ON 2/27 AND IT WAS LEAKING ON 2/29 SO IT WAS REPLACED. AFTER PULLING THE LINE, IT WAS FLUSHED AND SEEMED TO BE WORKING WITH NO LEAKING THROUGHOUT THE LINE. THE CATHETER HAD BEEN SECURED WITH STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770047 ↗
• MalfunctionApr 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "SHE PLACED A MIDLINE ON (B)(6) AND IT STARTED LEAKING AND NEEDED REPLACEMENT ON (B)(6). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765778 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "MIDLINE IN PLACE AND WORKING FINE FOR A FEW DAYS. RN CALLED FOR A CONSULT TO SEE IF DEVICE WAS LEAKING. PICC NURSE VISUALLY INSPECTED THE DEVICE AND IDENTIFIED A SMALL HOLE THAT LEAKED WHEN THE DEVICE WAS FLUSHED.¿ ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: "MIDLINE PLACED IN LEFT BASILIC VEIN ON (B)(6) 2023, CUT BACK TO 10CM. NO ISSUES, NO OBVIOUS LEAKS. ON (B)(6) 2023, CALLED TO ASSESS MIDLINE FOR LEAKING. WHEN AT BEDSIDE DRESSING IS VISIBLY WET UNDER THE TEGADERM. MIDLINE FLUSHES WITH EASE, VISUALIZED WITH ULTRASOUND IN VEIN, NO S/S OF INFILTRATION. I REMOVED THE DRESSING, FLUSHED THE MIDLINE AND OBSERVED SMALL AMOUNT OF FLUSH ESCAPING THE MIDLINE NEAR THE INSERTION SITE, I COULD NOT VISUAL WHERE THIS WAS COMING FROM EXACTLY, BUT EVERY TIME THE MIDLINE WAS FLUSHED THIS HAPPENED. ON (B)(6) 2023 MIDLINE WAS REMOVED AND REPLACED WITH NO ISSUES. AFTER REMOVING I INSPECTED THE LINE FOR HOLES AND CANNOT OBSERVE EXACTLY WHERE THIS IS COMING FROM. THERE WAS NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542234 ↗
• MalfunctionJan 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "PEELING OF INTRODUCER UPON INSERTION. OPENED SECOND KIT AND WAS ABLE TO PLACE INTRODUCER WITHOUT DIFFICULTY." (B)(6) 2023. ADDITIONAL INFORMATION PROVIDED: NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275056 ↗
• MalfunctionJan 25, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER "AFTER REMOVAL OF A 3 FR. POWERMIDLINE THE LINE WAS FOUND TO BE CUT OR TORN. THERE WAS NO HARM TO THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241900 ↗
• MalfunctionNov 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "HAVING ISSUES WITH THE DILATOR IN THEIR PROVENA 3F MIDLINE KIT FRAYING AT THE END OF THE DILATOR. NO HARM TO THE PATIENT, BUT I HAVE TO OPEN UP ANOTHER KIT TO REPLACE THE FRAYED 3FR MIDLINE DILATOR." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824534 ↗
• MalfunctionSep 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH WHILE PLACING 3FR. MIDLINE IN PATIENT'S RUA THE INTRODUCER FROM THE KIT WOULD NOT PASS INTO THE PATIENT'S VEIN. IT PIERCED THE SKIN WITHOUT DIFFICULTY BUT WOULD NOT THREAD. USED 3.5FR INTRODUCER FROM SEPARATE MICRO INTRODUCER KIT AND PASSED NEW INTRODUCER WITHOUT DIFFICULTY. UPON VISUAL INSPECTION, THE GREY PORTION OF THE ORIGINAL INTRODUCER APPEARS FRAYED AND CURLING UP SLIGHTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442131 ↗
• MalfunctionAug 31, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "CUSTOMER EXPERIENCING ISSUE WITH THE 3F INTRODUCER. INTRODUCER BENDS AND KINKS UPON INSERTION, RESULTING IN UNNECESSARY SKIN NICK RESULTING IN NECESSARY BLEEDING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331845 ↗
• InjuryAug 15, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "THE GUIDEWIRE BECAME STUCK IN THE VEIN, AND AFTER REMOVAL FRAGMENTS REMAINED IN THE PATIENT¿S TISSUE. THE SEQUENCE OF EVENTS ARE AS FOLLOWS: CEPHALIC VEIN WAS ATTEMPTED TWICE BY THE 1ST VASCULAR ACCESS NURSE. BASILIC VEIN ATTEMPTED IN THE SAME ARM. GAINED ACCESS WITH NEEDLE AND ATTEMPTED GUIDEWIRE. GUIDEWIRE WOULD NOT ADVANCE, ATTEMPTED TO PULL OUT BOTH NEEDLE AND WIRE TOGETHER, WIRE CAME OUT A LITTLE BIT BUT THEN WOULD NOT BUDGE. GUIDEWIRE WAS IN ARM APPROXIMATELY 2 CM. APPLIED HEAT, ASKED FOR ATIVAN PO WHICH WAS ADMINISTERED, ALSO ASKED FOR SURGERY CONSULT. SURGEON PULLED OUT WIRE AT BEDSIDE,  GUIDEWIRE CAME OUT WITH TIP FRAYED, SURGEON ORDERED AN XRAY FOR FRAGMENTS.  US WAS DONE TO CHECK VESSEL. XRAY REVEALED TINY FRAGMENT IN ARM, APPROXIMATELY 0.2-0.4 CM IN LENGTH (IN ESTIMATION). PATIENT DID RECEIVE HER MRI SUCCESSFULLY WITHOUT COMPLICATIONS."

  Patient problems: Foreign Body In Patient

  MAUDE report 15224947 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "THE INTRODUCERS TOO EASILY BUCKLING AND BECOMING BENT OR THE GREY PEEL-A-WAY END BEGINS TO CURL BACK ON ITSELF PREVENTING THE INTRODUCER FROM ENTERING THE VEIN WALL. WE WERE ABLE TO EASILY INSERT THE INTRODUCER THROUGH THE SKIN OVER THE GUIDE WIRE FOR ABOUT 1 INCH AFTER MAKING A SKIN NICK. HOWEVER, WHEN WE TRIED TO ADVANCE THE INTRODUCER THROUGH THE VEIN, WE MET RESISTANCE. WHEN WE TRIED TO ADVANCE THE INTRODUCER THROUGH THE VEIN, WE MET RESISTANCE. WE MADE A LARGER NICK BUT HAD THE SAME OUTCOME. WHEN WE REMOVED THE INTRODUCER I COULD SEE AND FEEL THE GRAY EDGE HAD ROLLED BACK ON ITSELF. WE HAD TO OPEN AN ADDITIONAL MIDLINE KIT TO RETRIEVE ANOTHER INTRODUCER. WHEN WE RETRIEVED A NEW INTRODUCER, IT ADVANCED EASILY LIKE IT'S SUPPOSED TO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204333 ↗
• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "ATTEMPTED TO INSERT DILATOR SHEATH, HAD NICK SKIN 3 TIMES, STILL UNABLE TO ADVANCE, NOTED FRACTURE IN THE PEEL WAY SHEATH, SECOND SHEATH DROPPED AND NOTED IT WAS BENT AT THE TIP, TWO CLINICIANS ATTEMPTED TO INSERT UNSUCCESSFULLY, DROPPED A 4FR DILATOR SHEATH AND WAS ABLE TO ADVANCE WITHOUT ISSUES." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136463 ↗
• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "ATTEMPTED TO INSERT DILATOR SHEATH, HAD NICK SKIN 3 TIMES, STILL UNABLE TO ADVANCE, NOTED FRACTURE IN THE PEEL WAY SHEATH, SECOND SHEATH DROPPED AND NOTED IT WAS BENT AT THE TIP, TWO CLINICIANS ATTEMPTED TO INSERT UNSUCCESSFULLY, DROPPED A 4FR DILATOR SHEATH AND WAS ABLE TO ADVANCE WITHOUT ISSUES." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136451 ↗
• MalfunctionJul 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "TODAY I HAVE HAD A MIDLINE PLACEMENT WHERE THE INTRODUCER FRAYED. I HAD TO MAKE A SMALL NICK (WHICH I DON¿T LIKE DOING) IN ORDER TO GET THE PIECE THROUGH THE SKIN, BUT THEN I COULD NOT PUSH THE PART INTO THE VEIN. WHEN THE PART WAS PULLED OUT AND INSPECTED IT WAS NOTICED THE INTRODUCER WAS FRAYED. A NURSE BROUGHT ME AN [NEW] MST KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033870 ↗