Power-Trialysis catheter 5605240Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741086977), received between Dec 29, 2015 and Aug 12, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

2 FDA recall records name this device's identifier, 2 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. Aug 10, 2026Class IOpen, Classified

   this is a downstream recall of class I recall RES 98777

   Z-2984-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. 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-2660-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222200 ↗
• MalfunctionFeb 24, 2026Material Frayed

  IT WAS REPORTED VIA MEDWATCH REPORT UNABLE TO ADVANCE CATHETER OVER WIRE WITH VISUALIZED PLASTIC DEFORMITY AT TIME ON INSPECTION. WHEN ATTEMPTED TO ADVANCE, WIRE BEGAN TO FRAY AND UNRAVEL. SECOND CATHETER KIT OBTAINED AND ADVANCED WITH SECONDARY PROVIDER AT BEDSIDE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430174 ↗
• MalfunctionOct 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT WAS SIGNIFICANT FRICTION/DIFFICULTY PASSING THE CATHETER OVER THE GUIDEWIRE. ULTIMATELY IT WAS POSSIBLE BUT WITH MORE FRICTION THAN NORMALLY EXPECTED. NO HARM TO THE PATIENT REPORTED. 9/30/2024 - THE GUIDEWIRE RETURNED FOR EVALUATION WAS FOUND TO BE KINKED AND SLIGHTLY MISALIGNED COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536648 ↗
• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED LINE DEVELOPED A MEMORY KINK IN THE LIMB WHERE WE CLAMP THE CLAMP AT, CAUSING FLOW ISSUES DURING DIALYSIS. IT WAS STATED A NEW LINE WAS USED BECAUSE THE KINK COULD NOT BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978175 ↗
• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED DEVICE STARTED DEVELOPING MEMORY KINKS IN THE LIMBS WHERE WE CLAMP THE CLAMPS AT CAUSING FLOW ISSUES DURING DIALYSIS. IT WAS STATED IT OCCURRED BY THE THIRD DAY AFTER INSERTION. ACUTE START HAD TO HAVE IT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977309 ↗
• MalfunctionJan 20, 2021Contamination /Decontamination Problem

  IT WAS REPORTED A BLACK HAIR COULD BE SEEN THROUGH THE PACKAGING OF A DIALYSIS CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11203256 ↗
• MalfunctionDec 31, 2015Torn Material

  FACILITY CONTACT REPORTED THAT A TRIALYSIS CATHETER WAS PLACED USING ULTRASOUND GUIDANCE. DOCTOR ALLEGED THAT THE WIRE AND CATHETER WERE PARTIALLY TORN BUT NOT COMPLETELY TORN IN HALF. REPORT STATED THAT THE PATIENT LOST BLOOD DUE TO HIGH VOLUMES. THE CATHETER WAS REMOVED AND A NEW ONE WAS IMPLANTED OK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5339176 ↗
• InjuryDec 29, 2015Failure to Advance; Device Or Device Fragments Location Unknown

  PER REPORT FROM DISTRIBUTER, STAFF WAS ASKED BY THE ED PHYSICIAN TO PLACE A MIDLINE CATHETER. PICC STAFF ATTEMPTED PLACEMENT OF A 20G/10CM POWERGLIDE MIDLINE CATHETER. THE VEIN WAS VISUALIZED BY ULTRASOUND AND THE CATHETER WAS INSERTED. BLOOD RETURN WAS NOTED AND THE GUIDEWIRE WAS ADVANCED WITHOUT DIFFICULTY. IT WAS REPORTED THAT WHEN ATTEMPTING TO THREAD THE CATHETER INTO THE VEIN, THE CATHETER WOULD NOT ADVANCE. THE STAFF WITHDREW THE CATHETER AND THE NEEDLE AND NOTICED THAT THE END OF THE CATHETER APPEARED SHORTER. COMPARED NEW MIDLINE CATHETER TO OLD ONE AND SAW THAT APPROXIMATELY 2CM OF THE CATHETER WAS ALLEGEDLY MISSING, LEFT TOURNIQUET ON AND NOTIFIED MD. A STAT X-RAY OF THE PATIENT ARM WAS ORDERED AND REVIEWED.

  Patient problems: Device Embedded In Tissue or Plaque; Test Result

  MAUDE report 5332576 ↗