Midline Catheter Kit P4154108Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741108754), received between Nov 30, 2017 and Apr 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (6 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-2662-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 WHEN IT WAS RETRACTED THE WIRE WAS LODGED, WHEN MORE PRESSURE WAS APPLIED THE SOFT TIP OF THE WIRE UNRAVELED AND FINALLY RELEASED.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 ↗
• MalfunctionJun 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDSUN WE WERE CALLED TO ICU TO PLACE MIDLINE IN PATIENT. DUE TO SOME SKIN BREAKDOWN DURING OUR ASSESSMENT MYSELF AND MY COWORKER DECIDED TO USE LEFT ARM FOR PLACEMENT. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ACCESS VEIN IN LEFT ARM, WE DECIDED TO SWITCH NURSES, AND I WOULD TRY TO GET ACCESS TO PLACE LINE. I WAS FINALLY ABLE TO ACCESS VEIN AND THREAD THE WIRE THROUGH THE NEEDLE, BUT THE WIRE WOULD NOT THREAD INTO THE VEIN. THIS IS A COMMON COMPLICATION WITH SOME LINE PLACEMENTS. WHEN THE WIRE WOULD NOT ADVANCE IN THE VEIN I TRIED TO PULL THE WIRE BACK AND REMOVE SO WE COULD MAKE ANOTHER ATTEMPT, BUT I MET WITH RESISTANCE IN SLIDING WIRE OUT OF VEIN. BECAUSE I FELT I RISKED A NEEDLE STICK WITH THE NEEDLE STILL IN PLACE AROUND THE WIRE I SLID THE NEEDLE OFF WIRE, AND THIS LEFT JUST THE WIRE IN THE PATIENT VEIN. I HAD DIFFICULT TIME ADJUSTING OR MOVING THE WIRE AS IT FELT LIKE IT WAS HUNG UP ON SOMETHING INSIDE THE ARM/VEIN. I WAS FINALLY ABLE TO GET THE WIRE TO MOVE IN THE ARM, GOT IT MOST OF THE WAY OUT AND IT GOT HUNG UP ON SOMETHING AGAIN, BUT I WAS CLOSE TO THE SURFACE OF THE SKIN BY THIS TIME. I TOOK MY BLADE AND MADE A VERY SMALL INCISION IN THE SKIN AROUND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322188 ↗
• MalfunctionMay 21, 2025Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, AFTER PICC NURSE, TRIMMED MIDLINE CATHETER, AND PRIOR TO ANY INSERTION IN PATIENT, NURSE STARTED TO PULL THE WIRE BACK TO LINE UP WITH THE TIP OF THE CATH. THE WIRE STRETCHED, AND STRETCHED, AND THE TIP WOULD NOT PULL BACK. THERE WAS NO INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064898 ↗
• MalfunctionMay 25, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT WIRE SHEARED BEFORE PLACING IN PATIENT. ADDITIONAL INFORMATION RECEIVED THE EVENT WAS DISCOVERED BY THE PERSON PERFORMING THE PROCEDURES WITNESSING THEM IN REAL TIME. NO REPORTED NEGATIVE OUTCOMES, JUST HAD TO GET NEW KITS AND START AGAIN. THERE WAS NOT A SERIOUS DELAY IN TREATMENT AS THEY WERE NOT EMERGENT LINE PLACEMENTS. THE ONE WAS FOR DE-ESCALATING PICCS PER OUR PROTOCOL SO THE PATIENT HAD AN ALTERNATE LINE. I CANNOT RECALL THE OTHER PATIENT BUT THE ONLY DELAY WAS GOING TO GET NEW KITS. THIS FILE ADDRESSES THE DELAY IN PROCEDURE FOR MIDLINE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17006695 ↗
• MalfunctionMay 25, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT WIRE SHEARED BEFORE PLACING IN PATIENT. ADDITIONAL INFORMATION RECEIVED: THE EVENT WAS DISCOVERED BY THE PERSON PERFORMING THE PROCEDURES WITNESSING THEM IN REAL TIME. NO REPORTED NEGATIVE OUTCOMES, JUST HAD TO GET NEW KITS AND START AGAIN. THERE WAS NOT A SERIOUS DELAY IN TREATMENT AS THEY WERE NOT EMERGENT LINE PLACEMENTS. THE ONE WAS FOR DE-ESCALATING PICCS PER OUR PROTOCOL SO THE PATIENT HAD AN ALTERNATE LINE. I CANNOT RECALL THE OTHER PATIENT BUT THE ONLY DELAY WAS GOING TO GET NEW KITS. THIS FILE ADDRESSES THE DE-ESCALATING PICC PER FACILITY PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17006671 ↗
• MalfunctionMay 16, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "AFTER PLACING A BARD TRADITIONAL POWERMIDLINE CATHETER AND UPON REMOVING THE STYLET/WIRE, I NOTICED THE WIRE SEEMED VERY LONG AND FRAGILE/FLIMSY IN APPEARANCE. I PUT THE EQUIPMENT ASIDE AND COMPLETED THE MIDLINE INSERTION BY FLUSHING AND CHECKING BLOOD RETURN. AFTER SUCCESSFULLY COMPLETING MID INSERTION, I EXAMINED THE WIRE AND IT APPEARED FRAYED AND FRACTURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941104 ↗
• MalfunctionJul 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "ON 6/25 OUR NURSES WENT TO PLACE A MIDLINE. UPON ATTEMPTING TO REMOVE THE LAST WIRE IS BECAME ¿STUCK¿ AND WAS UNABLE TO BE REMOVED. THEY REMOVED THE ENTIRE LINE BUT THE MIDDLE OF THE WIRE HAD UNRAVELED. (JUST THE MIDDLE PART). THE ENDS WERE STILL INTACT." REPORT FROM THE TM: "MIDLINE CATHETER PLACED WITHOUT DIFFICULTY. COULD NOT REMOVE FINAL WIRE AFTER PLACEMENT. HAD TO REMOVE ENTIRE CATHETER AND WIRE. WIRE HAD FRAYED(UNRAVELED) IN MIDDLE SECTION ONLY. ENDS WERE INTACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182343 ↗
• MalfunctionFeb 28, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED "REGARDING THE PEEL AWAY SHEET IN THE KIT, WHEN THEY BROKE IT AND WENT TO PEEL IT AWAY, IT BROKE AWAY FROM THE HANDLE AND THEY HAD TO USE FORCEPS TO REMOVE IT FROM THE PATIENT." ADDITIONAL INFORMATION RECEIVED: "PLACED IN PATIENT WHEN SHEATH WAS CRACKED AND PEELED, ONE SIDE OF THE SHEATH BECAME DETACHED FROM THE HANDLE. NEEDED TO BE REMOVED WITH FORCEP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9768705 ↗
• MalfunctionAug 30, 2019Misassembled

  IT WAS REPORTED THAT MIDLINE LUMEN WAS NOT PROPERLY THREADED THROUGH CLAMP. IT WAS STATED BECAUSE OF THIS, THE LUMEN WAS NOT ABLE TO BE CLAMPED CORRECTLY, THIS RESULTED IN MIDLINE HAVING TO BE EXCHANGED OVER GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8951898 ↗
• MalfunctionNov 30, 2017Retraction Problem; Unraveled Material

  FACILITY REPORTED TO SALES REP THAT THIS EVENT OCCURRED WHEN PREPARING THE CATHETER FOR PLACEMENT. FACILITY STATES THAT THE PREPARATION WAS DONE ACCORDING TO MANUFACTURER¿S INSTRUCTION. WHEN THE HEALTH PROFESSIONAL STARTED TO RETRACT THE STYLET THROUGH THE LOCKED T-LOCK THE STYLET DID NOT PULL BACK, IT UNRAVELED. ANOTHER MIDLINE KIT WAS OPENED AND FUNCTIONED PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7070615 ↗