Power-Trialysis catheter 5618150Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741041983), received between Nov 19, 2019 and Feb 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Deformation

  IT WAS REPORTED ONCE INSERTED THE GUIDEWIRE IS COILING. WE OPENED THREE CATHETERS FOR ONE PATIENT, BUT THE SAME PROBLEM OF GUIDEWIRE COILING. NO HARM WAS FOR THE PATIENT OF HCP, IT'S JUST A DELAY OF TREATMENT. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446635 ↗
• MalfunctionMay 23, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THE GUIDE-WIRE GOT LOOSE SUCH AS CRACK. IT WAS REPORTED THAT THE USER HAD FAILED, BECAUSE THE GUIDE WIRE WAS LOOSE WHEN USING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989532 ↗
• InjuryFeb 11, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER, THAT DURING CATHETER INSERTION, THEY WERE NOT ABLE TO REMOVE GUIDEWIRE AS IT BROKE IN A FEW PIECES. THEY WERE WORRIED THAT THE PIECE OF THE WIRE IS WITHIN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16359681 ↗
• MalfunctionDec 20, 2022Material Frayed; Material Frayed

  IT WAS REPORTED GUIDE WIRE CANNOT BE PULLED OUT AFTER CATHETER PLACEMENT. IT WAS STATED THE CONSERVATIVE MEASURES AND ACTION TAKEN WERE THE ENTIRE DEVICE IS REMOVED AND ANOTHER CATHETER IS INSERTED. (B)(6) 2022 - THE RETURNED GUIDEWIRE EXHIBITED MULTIPLE KINKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018270 ↗
• MalfunctionMar 18, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL ¿WHEN THE CAVA WAS LAID, THE GUIDE WIRE COULD NO LONGER BE ADVANCED, (ACCORDING TO DR. THERE MUST HAVE BEEN A SMALL KINK IN THE WIRE). WHEN THE WIRE WAS PULLED OUT, IT "DISSOLVED" ¿ ACCORDING TO DR. DID NOT USE EXCESSIVE FORCE. A CREASE WAS MADE BY US TO SEE HOW MUCH FORCE IS REQUIRED TO CAUSE THIS.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805591 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DILATOR COULD NOT GET INSERTED AT PUNCTURE SITE. (B)(6) 2021: THE RETURNED DILATOR WAS FOUND TO BE FLARED OUTWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757264 ↗
• MalfunctionJan 11, 2021Collapse; Material Deformation; Material Twisted/Bent; Material Deformation

  IT WAS REPORTED THAT ONE EXTENSION LEG OF TRIALYSIS WAS COLLAPSED AND KINKED. IT HAPPENED RIGHT AFTER OPENING THE CLAMP DURING INSERTION PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11152004 ↗
• MalfunctionNov 4, 2020Collapse; Material Deformation

  IT WAS REPORTED THAT ONE EXTENSION LEG OF TRYALYSIS WAS COLLAPSED AND KINKED. IT HAPPENED RIGHT AFTER OPENING THE CLAMP DURING INSERTION PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10788481 ↗
• MalfunctionNov 19, 2019Defective Component; Defective Component

  IT WAS REPORTED "WHEN THE WIRE WAS INSERTED, THERE WAS A FEELING THAT IT DID NOT GO SMOOTHLY." THE PATIENT HAD A HEMATOMA ON INSERTION SITE DUE TO EXTENDED PROCEDURE TIME.

  Patient problems: Hematoma

  MAUDE report 9342059 ↗
• MalfunctionNov 19, 2019Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent

  IT WAS REPORTED "WHEN THE WIRE WAS INSERTED, THERE WAS A FEELING THAT IT DID NOT GO SMOOTHLY." THE PATIENT HAD A HEMATOMA ON INSERTION SITE DUE TO EXTENDED PROCEDURE TIME. (B)(6) 2019 HEMATOMA WAS TREATED WITH PRESSURE THERAPY AND WAS RESOLVED.

  Patient problems: Hematoma

  MAUDE report 9341972 ↗