ARROW IPN030090Recalls & reported problems
Teleflex Incorporated · Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions · Class 2 · Implant
Quick summary
This Teleflex Arrow hemodialysis catheterization set is a two-lumen catheter kit with a blue FlexTip catheter used for high-volume infusions. The 60 reports mostly describe the guidewire arriving bent or kinked, sometimes twisted, unraveling, or stuck, along with cracked connectors and leaking blood or fluid. Five reports describe injuries such as pain, hematoma, bleeding, or anemia; no deaths. No recalls name this device. Reports dropped from 20 in the prior 12 months to none in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801902100146), received between Jul 11, 2023 and Sep 24, 2025 — classified as 5 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent28
- Unraveled Material12
- Physical Resistance/Sticking9
- Material Separation6
- Fluid/Blood Leak5
- Deformation Due to Compressive Stress4
- Crack3
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Anemia2
- Hematoma2
- Hemorrhage/Blood Loss/Bleeding2
- Intraoperative Pain2
- Easy Bruising1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR OPEN THE PACKAGE, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOVLEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23133267 ↗MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "(B)(6) 2025, BEFORE INSERTION, THE DOCTOR FOUND SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142741 ↗MalfunctionMay 7, 2025Crack; Gas/Air Leak; Crack; Gas/Air Leak
IT WAS REPORTED "THE CONNECTION BETWEEN THE NEEDLE AND SYRINGE IS CRACKED, MAKING IT IMPOSSIBLE TO DRAW WATER INTO THE SYRINGE AND INSTEAD ONLY DRAWING AIR." THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975969 ↗MalfunctionApr 16, 2025Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking
IT WAS REPORTED "THE WIRE WAS FOUND TO BE UNRAVELING." ADDITIONAL INFORMATION RECIEVED STATES "RESISTANCE WAS ENCOUNTERED DURING THE PROCESS OF INSERTING THE SWG THROUGH ULTRASOUND. THE SGW WAS PULLED BACK, TURNED, AND THEN ADVANCED." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21846607 ↗MalfunctionMar 31, 2025Crack; Crack
IT WAS REPORTED THAT THE DOCTOR FOUND LUER HUB HAS CRACK DURING USED ON THE PATIENT, ONE DAY AFTER THE INSERTION OF THE CATHETER. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731607 ↗MalfunctionMar 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DOCTOR FOUND SWG KINKED AND THE SWG CAN'T REMOVE IT. THEN REMOVE THE CATHETER DIRECTLY. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675851 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED WHEN THE SWG INSERTED INTO THE ARS DURING USED ON THE PATIENT." THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593653 ↗MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED WHEN OPENING THE PACKAGE PRIOR TO THE PATIENT." THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401422 ↗MalfunctionFeb 10, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "GUIDEWIRE KINKING."
Patient problems: Insufficient Information
MAUDE report 21344316 ↗MalfunctionFeb 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE GUIDE WIRE BENT". THEY CHANGED A NEW SET TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00131 AND 3006425876-2025-00132.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332705 ↗InjuryFeb 7, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT "THE SWG WAS INSERTED SMOOTHLY. THERE WAS A LITTLE RESISTANCE WHEN REMOVED, BUT IT WAS NOT DIFFICULT. THE DOCTOR DID NOT EXPECT THE SWG TO UNRAVEL, SO HE QUICKLY REMOVED IT, CAUSING THE UNRAVELLED SWG TO PUNCTURE THE NURSE. THE INJURED NURSE IS FINE AND HAD NO SERIOUS WOUNDS". THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00081 AND 3006425876-2025-00171.
Patient problems: Easy Bruising
MAUDE report 21332052 ↗MalfunctionFeb 7, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT "THE SWG WAS INSERTED SMOOTHLY. THERE WAS A LITTLE RESISTANCE WHEN REMOVED, BUT IT WAS NOT DIFFICULT. THE DOCTOR DID NOT EXPECT THE SWG TO UNRAVEL, SO HE QUICKLY REMOVED IT, CAUSING THE UNRAVELLED SWG TO PUNCTURE THE NURSE. THIS INCIDENT HAS BEEN REPORTED INTERNALLY, AND A NEW SET HAS BEEN OPENED. THE PATIENT IS FINE AND HAD NO HARM OR INJURY". THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00082, 3006425876-2025-00081 AND 3006425876-2025-00171.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332016 ↗MalfunctionFeb 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT: "THE SPRING IS STUCK AND CANNOT BE USED". ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303545 ↗MalfunctionJan 30, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "DURING THE INSERTION, WHEN THE CATHETER INSERTED INTO SWG, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272637 ↗MalfunctionJan 13, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT "THE SPRINGS AND WIRES OF THE DEVICE ARE BROKEN DURING USE." ADDITIONAL INFORMATION: "AFTER INSERTING GUIDEWIRE, THE DOCTOR FOUND THAT IT WAS NOT SMOOTH, SO HE PUSHED IT BACK, TOOK IT OUT AND FOUND THE GUIDEWIRE WAS BROKEN. THE DOCTOR TOOK IT OUT IN THE NORMAL WAY AND TOOK SOME TIME. NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. PATIENT IS FINE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137563 ↗MalfunctionJan 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED PRIOR TO USE ON THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21090984 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN THE SWG INSERTED INTO THE ARS DURING USED ON THE PATIENT. INVOLVED 3PCS." ASSOCIATED COMPLAINTS: 3006425876-2024-01100, 3006425876-2024-01101 AND 3006425876-2024-01065.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20607969 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT"09 OCT 2024, THE DOCTOR FOUND THE SWG KINKED WHEN THE SWG INSERTED INTO THE ARS DURING USED ON THE PATIENT. INVOLVED 3PCS." ASSOCIATED COMPLAINTS: 3006425876-2024-01100, 3006425876-2024-01101 AND 3006425876-2024-01065.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20607944 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT"(B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN THE SWG INSERTED INTO THE ARS DURING USED ON THE PATIENT. INVOLVED 3PCS." ASSOCIATED COMPLAINTS: 3006425876-2024-01100, 3006425876-2024-01101 AND 3006425876-2024-01065.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20607933 ↗MalfunctionNov 1, 2024Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove
IT WAS REPORTED "THE DOCTOR CHECKED THE EXPIRATION DATE OF THE PRODUCT BEFORE SURGERY, OPENED THE PRODUCT GUIDEWIRE WITHOUT OBVIOUS ABNORMALITY, THE GUIDEWIRE ENTRY IS NOT SMOOTH DURING THE PUNCTURE PROCESS, THE GUIDEWIRE IS DIFFICULT TO WITHDRAW AFTER THE COMPLETION OF THE PUNCTURE, AND THE GUIDEWIRE IS DIFFICULT TO WITHDRAW AFTER MANY TIMES OF ADJUSTING THE POSITION AND THE CATHETER, AND THE GUIDEWIRE IS SEEN ABNORMAL AFTER THE WITHDRAWAL, AND IT BENDS IN MANY PLACES, AND THERE IS THE RISK OF REPEATED PUNCTURE, WHICH IS EASY TO LEAD TO THE RISK OF SECONDARY INJURIES." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20585531 ↗MalfunctionOct 21, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE RESISTANCE WHEN THE SWG INSERTED INTO THE ARS DURING USE ON THE SAME PATIENT. THE SWG WAS FOUND KINKED WHEN WITHDRAWING THE SWG. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491336 ↗MalfunctionOct 21, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED "ON 13 SEP 2024, THE DOCTOR FOUND THE RESISTANCE WHEN THE SWG INSERTED INTO THE ARS DURING USE ON THE SAME PATIENT. THE SWG WAS FOUND KINKED WHEN WITHDRAWING THE SWG. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20491054 ↗MalfunctionOct 9, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT." THE USER CHANGED A NEW ONE. THERE IS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409254 ↗MalfunctionOct 8, 2024Difficult to Insert; Difficult to Remove; Material Twisted/Bent; Difficult to Insert; Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED "ON 12 SEP 2024, THE DOCTOR FOUND IT WAS DIFFICULT WHEN THE SWG INSERTS AND WITHDRAWS FROM THE ARS. THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398277 ↗MalfunctionSep 23, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT: "(B)(6) 2024 , AFTER INSERTION, THE CATHETER WAS FOUND TO BE BLOCKED DURING USE ON THE PATIENT. IT WAS RESOLVED BY CHANGING TO A NEW ONE. NO HARM FOR THE PATIENT. INVOLVED 1 PC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20277210 ↗
Other Catheter, hemodialysis, triple lumen, non-implanted devices
- Power-Trialysis catheter 5605150Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- MAHURKAR 8888101002HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls1 death8 reports
- MAHURKAR 8888102003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615200Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis Slim-Cath catheter 5855240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888101003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102004HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.