ARROW IPN030207Recalls & reported problems
Teleflex Incorporated · You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter for High Volume Infusions · Class 2
Quick summary
This Arrow You-Bend hemodialysis catheter set is used for dialysis and high-volume infusions. The 24 reports mostly describe kinked or bent guidewires and catheters that block smooth passage, with some mentions of parts separating or coming unraveled, and no deaths and no injuries. No recalls name this device.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801902100252), received between Aug 10, 2023 and Feb 17, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (15 reports).
5 other recalls cover devices cleared under the same FDA submission (K993933); they may or may not involve this specific model.
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/Bent15
- Material Separation5
- Physical Resistance/Sticking5
- Contamination /Decontamination Problem2
- Deformation Due to Compressive Stress1
- Device Damaged Prior to Use1
- Difficult to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Material Separation
IT WAS REPORTED THAT: "ON (B)(6) 2026, THE NEEDLE CANNUAL SEPARATED FROM HUB DURING USED ON THE PATIENT. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363077 ↗MalfunctionJan 22, 2026Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT: "THE OCCLUSION OF THE CENTRAL LUMEN OF ARS PREVENTED THE GUIDEWIRE FROM PASSING THROUGH SMOOTHLY, RESULTING IN GUIDEWIRE DEFLECTION. THE SAME ISSUE PERSISTED EVEN AFTER THE CATHETER WAS REPLACED, YET THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. THE SECOND SWG/ARS THAT HAD RESISTANCE BUT WAS ABLE TO COMPLETE THE PROCEDURE WAS FOUND KINKED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINT 3006425876-2026-00050.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24143137 ↗MalfunctionJan 16, 2026Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED THAT: "(B)(6) 2025, THE OCCLUSION OF THE CENTRAL LUMEN OF ARS PREVENTED THE GUIDEWIRE FROM PASSING THROUGH SMOOTHLY, RESULTING IN GUIDEWIRE DEFLECTION AND KINKING. THE SAME ISSUE PERSISTED EVEN AFTER THE CATHETER WAS REPLACED. THE SECOND SWG AND ARS WERE USED ON THE PATIENT. ALTHOUGH THERE IS RESISTANCE, THE DOCTOR ADJUSTED THE PUNCTURE ANGLE AND THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. NO THIRD SWG AND ARS WERE USED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093362 ↗MalfunctionJan 16, 2026Material Twisted/Bent
IT WAS REPORTED THAT: "(B)(6) 2024, PRIOR TO CATHETERIZATION, TEACHER FROM THE EMERGENCY DEPARTMENT IDENTIFIED THE SWG KINKED. NO PATIENT INVOLVED.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092833 ↗MalfunctionJan 14, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, THE SWG WAS FOUND KINKED DURING USE 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. NO MORE OTHER INFORMATION CAN BE PROVIDE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066010 ↗MalfunctionJan 7, 2026Material Twisted/Bent
IT WAS REPORTED THAT: "(B)(6) 2024, BEFORE INSERTION, HEALTH PROFESSIONAL IN EMERGENCY DEPARTMENT FOUND THAT THE GUIDEWIRE WAS KINKED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987626 ↗MalfunctionDec 31, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT: "(B)(6) 2025, THE SWG WAS FOUND UNRAVELED DURING USE ON THE PATIENT. ANOTHER SWG WAS USED SUCCESSFULLY. THERE WAS NO HARM OR CONSEQUENCE FOR THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932494 ↗MalfunctionJul 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT "THERE IS A WHITE FOREIGN OBJECT AT THE FRONT END OF THE TUBING." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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 22411302 ↗MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING THE INSERTION. THEY CHANGED TO A NEW ONE. NO HARM FOR THE PATIENT." 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 20693737 ↗MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING THE INSERTION. THEY CHANGED TO A NEW ONE. NO HARM FOR THE PATIENT." 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 20693684 ↗MalfunctionNov 14, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING THE INSERTION. THEY CHANGED TO A NEW ONE. NO HARM FOR THE PATIENT." 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 20685554 ↗MalfunctionNov 14, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING THE INSERTION. THEY CHANGED A NEW ONE. NO HARM FOR THE PATIENT." 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 20685383 ↗MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2024, CCU THE DOCTOR FOUND THE SWG KINKED PRIOR TO THE PATIENT. THEY CHANGED TO A NEW ONE." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20459886 ↗MalfunctionJun 6, 2024Material Separation; Material Separation
IT WAS REPORTED "THE DOCTOR FOUND THE SWG SEPARATED DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE. NO IMPACT FOR THE PATIENT." THE DEVICE WAS REMOVED ENTIRELY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476160 ↗MalfunctionJun 2, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT "WHEN THE SWG INSERTED INTO THE ARS, THE DOCTOR FOUND RESISTANCE, THE SWG KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444838 ↗MalfunctionMay 21, 2024Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Damaged Prior to Use; Contamination /Decontamination Problem
IT WAS REPORTED "THE LUER HUB WAS FOUND FLATTED PRIOR TO THE PATIENT." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19358523 ↗MalfunctionMay 1, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE SWG WAS FOUND KINKED BEFORE INSERTION PRIOR TO THE PATIENT. THEY CHANGED A NEW ONE." NO PATIENT INVOLVEMENT WAS REPORTED THEREFORE NO PAITENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219905 ↗MalfunctionMar 20, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: "ON (B)(6) 2024, THE HOSPITAL EXPERIENCED TWO CONSECUTIVE CASES OF SWG SEPARATED DURING USE ON THE SAME PATIENT. INVOLVED 2 PC. AFTER THAT THE CATHETER WAS REPLACED, NO POTENTIAL DANGER TO THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18938845 ↗MalfunctionMar 18, 2024Material Separation; Material Separation
IT WAS REPORTED "THE HOSPITAL EXPERIENCED TWO CONSECUTIVE CASES OF SWG SEPARATED DURING USED ON THE SAME PATIENT." AS A RESULT THE CATHETER WAS REPLACED. 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 18920677 ↗MalfunctionFeb 29, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED "THE DOCTOR FOUND THE RESISTANCE BETWEEN SWG AND ARS, THE SWG WAS FOUND KINKED DURING USED ON THE SAME PATIENT." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS 3006425876-2024-00202 AND 3006425876-2024-00201.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806570 ↗MalfunctionFeb 29, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED "THE DOCTOR FOUND THE RESISTANCE BETWEEN SWG AND ARS, THE SWG WAS FOUND KINKED DURING USED ON THE SAME PATIENT." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER 3006425876-2024-00191 AND 3006425876-2024-00201.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806531 ↗MalfunctionFeb 29, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED "THE DOCTOR FOUND THE RESISTANCE BETWEEN SWG AND ARS, THE SWG WAS FOUND KINKED DURING USED ON THE SAME PATIENT." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE 3006425876-2024-00191 AND 3006425876-2024-00202.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806523 ↗MalfunctionAug 22, 2023Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND SEPARATED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WITH DEVICE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596788 ↗MalfunctionAug 10, 2023Material Deformation; Material Deformation
IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON THE PATIENT. "THE SUPERIOR PHYSICIAN INSTRUCTED EMERGENCY PLASMA EXCHANGE TREATMENT. AT 19:10, THE TIP OF THE EXPANDER WAS SPLIT IN HALF DURING THE RIGHT JUGULAR VEIN CATHETERIZATION, WHICH COULD NOT BE SEEN CAREFULLY AND COULD NOT BE USED NORMALLY." THE PHYSICIAN WAS CALLED TO ASSIST WITH CATHETERIZATION. "DUE TO THE PATIENT'S AGING AND THINNER SKIN, THE CATHETER WAS SLOWLY INSERTETED AND FINALLY SUCCEEDED WITHOUT CAUSING ANY ADVERSE EFFECTS ON THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17498804 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K993933. One submission often covers many models, so check the product and lot details in each record.
- Z-2373-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYS
- Z-1336-2018 · Dec 22, 2017 · TerminatedARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1
- Z-0658-2018 · Oct 17, 2017 · TerminatedARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2
- Z-2334-2017 · May 9, 2017 · Terminated1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation
- Z-0639-04 · Feb 18, 2004 · TerminatedTwo Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices
- MAHURKAR 8888135191Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall175 reports
- MAHURKAR 8888135241Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death100 reports
- ARROW IPN036723Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls2 reports
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex Incorporated · Catheter, hemodialysis, non-implanted2 recalls0 reports
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.