Power-Trialysis catheter 5605150Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741086953), received between Mar 28, 2017 and Aug 25, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Material Frayed

  It was reported via MedWatch that retained guidewire. Required intervention. No further details provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50434965 ↗
• InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PATIENT WAS PLACED WITH THE TRIALYSIS LINE. IN LESS THAN 24 HOURS, WHEN DREW BLOOD FROM THE LINE ABOUT AT LEAST 40CC OF AIR WAS DRAWN, CT SCAN ALSO INDICATES AIR AT THE LEFT SIDE OF THE NECK, PATIENT CURRENTLY UNDER OBSERVATION AND SUPPORTIVE MEASURES FOR AIR EMBOLISM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism

  MAUDE report 23000491 ↗
• MalfunctionSep 18, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT THE TRIALYSIS CATHETER PLASTIC PIECE THAT SUPPORTS THE SUTURES CAME OFF WHICH LED TO THE TRIALYSIS CATHETER MIGRATING OUT OF THE PATIENT. THE SUTURE PIECE STAYED INTACT TO THE SKIN BUT CAME OFF THE CATHETER. "WHEN TURNING THE PATIENT THE PLASTIC PIECE REMAINED SUTURED TO THE PATIENT BUT THE ACTUAL LINE BROKE AWAY AND CAME OUT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252953 ↗
• MalfunctionMay 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE WIRE WAS GETTING STUCK WHILE THEY WERE TRYING TO THREAD THE WIRE THROUGH THE NEEDLE AND REPORTED THE WIRE WAS STUCK INSIDE THE NEEDLE WHEN THEY ATTEMPTED TO RETRACT. (B)(6) 2024 - THE GUIDEWIRE RETURNED FOR EVALUATION WAS FOUND TO HAVE A SLIGHT KINK TOWARDS THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226563 ↗
• MalfunctionJun 22, 2023Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  IT WAS REPORTED BY OUR NURSE, IT LOOKS LIKE THE HOLDER WAS DEFECTIVE BECAUSE THE SUTURES ARE COMPLETELY INTACT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER: THE PATIENT LINE WAS REMOVED AND REPLACED BY A FUNCTIONING TRIALYSIS. IT REQUIRED AN ADDITIONAL PROCEDURE AND CENTRAL LINE REMOVAL AND REPLACEMENT ON THIS PATIENT. IT REQUIRED MONITORING FOR SIGNS/SYMPTOMS OF CENTRAL LINE INFECTION SINCE THE CATHETER WAS NOT SECURE AND HAD DISLODGED LEAVING IT EXPOSED. THE LINE WAS BEING USED FOR DIALYSIS OF THE PATIENT. IT DISRUPTED CARE BUT NOT FOR A SIGNIFICANT AMOUNT OF TIME. THE PATIENT REQUIRED THE REMOVAL AND REPLACEMENT OF THE LINE. RESULTING IN AN ADDITIONAL CHEST XRAY. CATHETER WAS DISLODGED, THE ORIGINAL INSERTION LENGTH WAS: 15CM REPLACED IMMEDIATELY AFTER REMOVAL. IT DID NOT CAUSE A SIGNIFICANT DELAY. WE WERE ABLE TO REPLACE THE LINE QUICKLY WITHOUT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182611 ↗
• MalfunctionJun 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT A RIJ TRIALYSIS DISLODGED. THEY THINK THE HOLDER WAS DEFECTIVE BECAUSE THE SUTURES ARE COMPLETELY INTACT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166571 ↗
• InjurySep 4, 2019Device Alarm System; Break

  IT WAS REPORTED THAT "EEG TECH AT PATIENT BEDSIDE REMOVING EEG LEADS (DID NOT HAVE SCISSORS). PATIENT WITH CRRT RUNNING THROUGH RIGHT IJ TRIALYSIS CATHETER WITH NO PROBLEMS IDENTIFIED. CRRT MACHINE RED ALARMED. THIS RN IMMEDIATELY TO BEDSIDE TO ADDRESS ALARM. ALARM INDICATED ARTERIAL AIR. THIS RN NOTICED AIR FILLED ARTERIAL CRRT LINE. UPON ASSESMENT, VAS CATH SITE WAS BLEEDING. BOTH LUMENS OF VAS CATH CLAMPED. FURTHER ASSESSMENT REVEALED ARTERIAL ACCESS LINE OF VAS CATH TRANSECTED/BROKE IN HALF. PRESSURE HELD TO RIGHT IJ VAS CATH SITE. MD IMMEDIATELY TO BEDSIDE TO ASSIST IN HOLDING PRESSURE. LINE EMERGENTLY REMOVED BY MD. PATIENT PLATELETS ARE IN 30S. CRRT FILTER BLOOD LOSS (170ML) AND SATURATION OF 3 PACKS OF 4X4 GAUZE/BED PAD. HEMOGLOBIN REMAINED STABLE POST INCIDENT, THOUGH PATIENT ON THREE PRESSORS: LEVO AT 30, EPI AT 9, AND VASO. EPI WAS INCREASED TO 15 TO MAINTAIN BP DURING INCIDENT. PHOTOS TAKEN OF VAS CATH AND GIVEN TO CLINICAL EDUCATOR. VAS CATH UNABLE TO BE IMMEDIATELY REPLACED AND PATIENT WILL BE GOING WITHOUT NEEDED CRRT UNTIL LINE IS REPLACED." IT WAS STATED THAT THE PATIENT "LOST A CONSIDERABLE AMOUNT OF BLOOD CAUSING MORE MEDICATION USE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8960257 ↗
• InjurySep 7, 2018Insufficient Device Problem Information

  THE FACILITY REPORTED AN EVENT IN WHICH A PATIENT BEING TREATED WITH TL ACUTE POWER DIALYSIS CATHETER CODED. WHEN AN ULTRASOUND WAS PERFORMED, AIR WAS DISCOVERED IN BOTH THE ATRIUM AND THE VENTRICLE. ALL OF THE DEPARTMENT WAS NOTIFIED TO PAY CLOSE ATTENTION TO THE TUBING, MACHINE, AND CATHETER, AND THEY WERE ABLE TO RULE OUT THE DIALYSIS MACHINE AS THE PROBLEM.

  Patient problems: Air Embolism

  MAUDE report 7857927 ↗
• MalfunctionSep 7, 2018Gas/Air Leak

  THE FACILITY REPORTED THAT THEY PULLED A NEW CATHETER OUT OF A KIT TO TEST AND DETERMINED THAT THERE APPEARS TO BE LEAKING OF AIR INTO THE ARTERIAL EXTENSION LEG AT THE JUNCTION TO THE HUB OF THE CATHETER (WHERE THE SUTURE HOLES ARE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857223 ↗
• MalfunctionSep 7, 2018Gas/Air Leak

  THE FACILITY REPORTED THAT ABOUT A MONTH AND A HALF AGO, AIR WAS DISCOVERED IN THE ARTERIAL LEG OF THE CATHETER. IT WAS STATED THEY DID NOT KNOW THE CAUSE AND DID NOT INVESTIGATE THE CATHETER. (B)(6) 2018- IT WAS STATED THAT THE CATHETERS WERE SUTURED IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857220 ↗
• MalfunctionSep 7, 2018Gas/Air Leak

  THE FACILITY REPORTED THAT ON (B)(6) 2018, THE RN VERIFIED THAT NO AIR WAS PRESENT IN LINE PRIOR TO STARTING CVVH. SHORTLY AFTER THE MACHINE WAS TURNED ON, THE ALARM WENT OFF INDICATING THAT AIR WAS PRESENT IN THE ARTERIAL LINE. THE RN TURNED OFF THE MACHINE, CLAMPED THE LINE AND COULD SEE AIR IN THE EXTENSION LEG OF THE ARTERIAL LUMEN. ON 9/4/2018: ADDITIONAL INFORMATION REC'D: THE CATHETER HAD BEEN IN PLACE FOR APPROXIMATELY 11 DAYS AND WAS SUTURED AND SORBAVIEW DRESSING WAS USED. THE PATIENT HAD BEEN ON CVVH INTERMITTENTLY FOR SEVERAL DAYS. THE MACHINE¿S ALARM INDICATED THAT THERE WAS AIR IN THE LINE. ALL LINES AND THE MACHINE WERE DOUBLE CHECKED BY TWO STAFF MEMBERS AT TIME OF CVVH INITIATION, AND AGAIN BY TWO STAFF MEMBERS WHEN THE MACHINE ALARMED. TROUBLESHOOTING THE MACHINE AND LINES LED TO NOTICING THE ISSUE WITH THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857218 ↗
• MalfunctionAug 9, 2018Material Deformation

  IT WAS REPORTED THAT ON 6/23/18 THE RN INFUSED THROUGH THE TRIALYSIS CATHETER AND NOTICED A BULGE IN THE EXTENSION LEG. THE CATHETER WAS REMOVED AND ANOTHER ONE WAS REPLACED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770626 ↗
• MalfunctionMar 28, 2017Sticking

  IT WAS REPORTED BY RISK MANAGEMENT THAT DURING INSERTION OF THE CATHETER, THE GUIDEWIRE WAS STUCK TOGETHER. ANOTHER KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION WAS AVAILABLE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6440568 ↗