Midline Catheter Kit P4154108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00801741108761), received between Oct 4, 2016 and Aug 12, 2026 — classified as 1 death, 9 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220753 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionMar 6, 2026Material Frayed

  IT WAS REPORTED THE GUIDEWIRE IN MST MIDLINE KIT UNRAVELING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532071 ↗
• MalfunctionFeb 24, 2026Difficult or Delayed Separation

  IT WAS REPORTED DURING PLACEMENT OF A MIDLINE THE INTRODUCER DID NOT SPLIT CORRECTLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429699 ↗
• MalfunctionJan 20, 2026Unsealed Device Packaging

  IT WAS REPORTED BY CUSTOMER THAT THE KIT WAS OPEN BEFORE ANYONE PHYSICALLY OPENED IT. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118130 ↗
• MalfunctionAug 6, 2025Defective Component; Defective Component

  IT WAS REPORTED, 12 STYLETS TO HAVE MULTIPLE MICRO RAZED AREAS THIS REPORT ADDRESSES ALL TWELVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734407 ↗
• MalfunctionAug 4, 2025Activation Problem; Activation Problem

  ADDITIONAL INFORMATION: THERE WAS NO NEEDLE STICK INJURY, IT JUST SCRATCHED THE GLOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701813 ↗
• MalfunctionAug 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT NEEDLE FAILED TO SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700834 ↗
• MalfunctionJul 31, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT INTRODUCER FAILED TO SEPARATE PROPERLY AND HAD TO BE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680829 ↗
• MalfunctionJun 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE STYLET IN THE PICC WOULD NOT UNSCREW SO THEY COULD TAKE IT OUT. THE EVENT RESULTED IN NEEDING TO OVER THE WIRE EXCHANGE FOR A NEW MIDLINE FOR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298646 ↗
• MalfunctionApr 3, 2025Activation Problem; Activation Problem

  ADDITIONAL INFORMATION: THERE WAS NO ADVERSE EVENT OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764040 ↗
• MalfunctionApr 3, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE WIRE FRAYED WHEN THREADING INTO THE NEEDLE. NO HARM OR INJURY OCCURRED DURING THIS INCIDENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762306 ↗
• MalfunctionMar 31, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER WHEN TRYING TO ACTIVATE SAFETY, THE SAFETY SLID OFF THE NEEDLE AND DETACHED. THERE WAS NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733156 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE POWER-MIDLINE CATHETER SEVERED AT THE EXTENSION SET. ADDITIONAL INFORMATION RECEIVED 2/24/2025: IT WAS REPORTED RN ENTERED THE PATIENT'S ROOM AND DISCOVERED THE MIDLINE APPEARED TO BE SEVERED BETWEEN THE CATHETER AND CLAMP. NO HARM TO PATIENT, PATIENT REQUIRED NEW IV PLACEMENT FOR CONTINUED MEDICATION. MIDLINE CLOTTED UPON SEVERING OF LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528632 ↗
• MalfunctionDec 4, 2024Activation Problem; Activation Problem

  IT WAS REPORTED A NEEDLE MALFUNCTION, AS I WAS PULLING THE GREEN SAFETY MECHANISM DOWN IT JUST CAME RIGHT OFF. I DIDN¿T PULL IT HARD. IT JUST SLIPPED RIGHT OFF THE END. I DIDN¿T GET POKED LUCKILY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848237 ↗
• MalfunctionNov 7, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT THIS PARTICULAR MIDLINE KIT CANNOT PULL THE STIFFENING STYLET AND WHEN SHE TRIED TO PULL HARDLY AGAINST THE T LOCK, THE STYLET STARTED TO STRETCH AND SHRED. DECIDED TO PLACE THE CATHETER WITHOUT THE STYLET. NO OTHER INFORMATION PROVIDED AT THIS TIME. ADDITIONAL INFORMATION PROVIDED 10/28/2024: THE RESULT OF THE MALFUNCTION DID DIRECTLY AFFECT THE PATIENT AS THE NEEDLE AND GUIDEWIRE WERE IN THE PATIENT WHEN IT BECAME STUCK, AND THEY COULD NOT REMOVE OR THREAD AFTER THE VEIN WAS CANNULATED. THE GUIDEWIRE WAS PLACED WITH EASE AND NO OBVIOUS ABNORMALITIES NOTED. AFTER THE INTRODUCER WAS INSERTED, THE RN WAS NOT ABLE TO REMOVE GUIDEWIRE. MULTIPLE ATTEMPTS WERE MADE AND AFTER SEVERAL MINUTES SHE WAS ABLE TO REMOVE THE GUIDEWIRE AND IT WAS NOTED TO BE BENT AND FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631503 ↗
• MalfunctionSep 19, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT PUT IN A TRIMMABLE MIDLINE AND PULLED THE WIRE AND IT WAS SPLIT IN 2 PIECES. NO INJURY TO THE PATIENT OR HEALTHCARE PROFESSIONAL. PATIENT RECEIVED CHEST XRAY TO CONFIRM THERE WERE NO WIRE FRAGMENTS LEFT IN ARM. UPON REMOVAL WIRE WAS SPLIT IN 2 SEPARATE THREADS. LIKE THE WIRE SEPARATED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263557 ↗
• InjurySep 12, 2024Break; Break

  IT WAS REPORTED, MIDLINE CAME APART IN A PATIENT'S ARM. IT WAS A 20CM PROVENA MIDLINE, LOT NUMBER REJQ1293. UNEVENTFUL INSERTION ON (B)(6) 2024- PLACED IN LEFT BASILIC VEIN IN ONE ATTEMPT WITH GREAT BLOOD RETURN AND EASY FLUSH AFTER INSERTION. WAS USED FOR INTERMITTENT INFUSIONS THROUGHOUT THE NEXT 24 HOURS. NURSING TRIED TO FLUSH ABOUT 24 HOURS AFTER INSERTION AND COULD NOT FLUSH. IV TEAM WAS CONSULTED AND WE COULD NOT FLUSH IT EITHER. NURSE TOOK DOWN THE DRESSING AND PULLED IT BACK A FEW CENTIMETERS (IT WAS 20CM LONG) AND STILL COULD NOT GET IT TO FLUSH SO DECISION WAS MADE TO PULL LINE. LINE WAS REMOVED WITHOUT ANY RESISTANCE, BUT ONLY 7CM UPON REMOVAL. IMMEDIATELY PLACED A TOURNIQUET, GOT AN X-RAY AND ULTRASOUND (WHICH DEMONSTRATED THAT THE RETAINED MIDLINE WAS IN THE AXILLARY VEIN). IR HAD TO RETRIEVE RETAINED MIDLINE THAT NIGHT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20205910 ↗
• MalfunctionAug 8, 2024Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED VIA MEDWATCH, POWER MIDLINE CATHETER HAD A FRAYED GUIDEWIRE. THIS WAS NOTICED BEFORE THE LINE WAS PLACED IN THE PATIENT. PROCEDURE WAS PAUSED WHILE A COLLEAGUE OBTAINED A NEW MIDLINE KIT. WHEN NEW KIT ARRIVED, NEW LINE WAS INSPECTED AND FOUND TO BE WITHIN NORMAL LIMITS. PROCEDURE COMPLETED WITH NO FURTHER ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939071 ↗
• MalfunctionJul 1, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY MEDWATCH PATIENT REQUIRED MIDLINE. DURING MIDLINE INSERTION, PEEL-AWAY INTRODUCER FAILED TO SEPARATE PROPERLY CAUSING CATHETER TO WITHDRAW. REQUIRED INTRODUCER TO BE CUT TO BE REMOVED. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644965 ↗
• MalfunctionJun 28, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED VIA MEDWATCH PATIENT REQUIRED MIDLINE FOR IV VANCOMYCIN. DURING MIDLINE INSERTION, PEEL-AWAY INTRODUCER FAILED TO SEPARATE PROPERLY - CAUSING CATHETER TO WITHDRAW. REQUIRED INTRODUCER TO BE CUT TO BE REMOVED. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639481 ↗