CT Midline Catheter MLCT4S20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884908113730), received between Jun 19, 2020 and Aug 7, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Difficult to Remove

  During Midline insertion guidewire lodged in the subcutaneous tissue. During the difficult removal process, a knot was observed in the guidewire.

  Patient problems: Insufficient Information

  MAUDE report 50172846 ↗
• InjurySep 3, 2025Break; Break

  DEVICE WAS IMPLANT ON (B)(6) 2025. PATIENT SUFFERS FROM SEVERAL DISEASES AND UNDERWENT CT SCAN. THE IMAGES SHOWED A TUBULAR, HYPERDENSE MATERIAL IN THE PULMONARY ARTERIAL BRANCHES, LIKELY TO BE A CATHETER FRAGMENT. THE DEVICE WAS FOUND TO BE "TRUNKED" AND REMOVED. PATIENT WAS KEPT UNDER OBSERVATION FOR SEVEN DAYS WITHOUT ANY COMPLICATIONS BEING OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22952324 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  ULTRASOUND GUIDED VEIN IDENTIFICATION BEFORE POSITIONING THE CATHETER. THE NEEDLE WAS INSERTED INTO THE VEIN. WHEN VENOUS BLOOD FLOWED BACK, THE GUIDEWIRE WAS INTRODUCED AND PROCEEDED INTO THE VEIN A FEW CENTIMETERS BUT THEN IT STOPPED. THE NEEDLE WAS REMOVED, WHILE THE GUIDE WAS STUCK UNDER THE SKIN AND DOES NOT COME OUT. TRACTION WAS PERFORMED UNTIL IT CAME OUT. COMPRESSIVE BANDAGE WAS APPLIED. THE GUIDEWIRE WAS KNOTTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463241 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DURING MIDLINE INSERTION ON RIGHT BRACHIAL VEIN, GUIDEWIRE WELL POSITIONED WITH ULTRASOUND, AFTER PEEL-AWAY INSERTION, GUIDEWIRE REMOVAL WAS LIMITED BY OBSTACLES. ALL PEEL-AWAY PLUS GUIDEWIRE WAS REMOVED AND THE TIP OF GUIDEWIRE WAS KNOTTED. NEW PROCEDURE WAS STARTED, COMPRESSION TO REDUCE HEMATOMA, NEW SET WAS USED AND PLACED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792183 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DURING MIDLINE INSERTION ON RIGHT BRACHIAL VEIN, GUIDEWIRE WELL POSITIONED WITH ULTRASOUND, AFTER PEEL-AWAY INSERTION, GUIDEWIRE REMOVAL WAS LIMITED BY OBSTACLES. ALL PEEL-AWAY PLUS GUIDEWIRE WAS REMOVED AND THE TIP OF GUIDEWIRE WAS COILED. AFTER SMALL BLEEDING STOP, NEW SET WAS USED AND PLACED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792174 ↗
• MalfunctionSep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DIFFICULT GUIDEWIRE REMOVAL. IT KNOTTED ON THE DISTAL TIP. IR PROCEDURE TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439233 ↗
• MalfunctionJul 22, 2020Fracture; Fracture

  LINE FRACTURED WHILE IN USE, MEDICATION LEAKING FROM CRACK IN LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10308262 ↗
• MalfunctionJun 19, 2020Break; Break

  GUIDEWIRE TIP KNOTTED AND BROKE INTO FOUR (4) PIECES WHICH REQUIRED SURGERY FOR REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174159 ↗