ARROW IPN030213Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801902100276), received between Jul 6, 2023 and Mar 26, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2026, DUE TO THE PATIENT'S CONDITION REQUIRING CONTINUOUS HEMODIALYSIS, A HEMODIALYSIS CENTRAL VENOUS CATHETER WAS INSERTED BY THE PHYSICIAN AT THE BEDSIDE. DURING THE PROCEDURE, THE GUIDEWIRE IN THE KIT WAS FOUND TO BE KINKED. THE NURSE MANAGER WAS NOTIFIED IMMEDIATELY, AND A NEW CATHETERIZATION KIT WAS REPLACED. 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 24697572 ↗
• MalfunctionFeb 25, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2026, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT. THEY CHANGED TO OTHER BRAND TO RESOLVE THE ISSUE. THERE WAS NO HARM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441760 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2025, A FEMORAL VEIN CATHETERIZATION WAS PERFORMED ON THE PATIENT USING A CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS TO ESTABLISH A BLOOD PURIFICATION ACCESS FOR DFPP TREATMENT. NO ABNORMALITIES WERE DETECTED DURING THE CATHETER INSPECTION PRIOR TO PLACEMENT, AND THE CATHETERIZATION PROCEDURE PROCEEDED SMOOTHLY WITHOUT INCIDENT. DURING THE TREATMENT PERIOD, THE ON-DUTY NURSE REPORTED A LOW FLOW RATE; GIVEN THAT DFPP TREATMENT DOES NOT IMPOSE HIGH REQUIREMENTS ON FLOW RATE, NO INTERVENTION WAS IMPLEMENTED. THE CATHETER WAS REMOVED FROM THE PATIENT AT 19:00 ON (B)(6) 2025. POST-REMOVAL INSPECTION REVEALED THAT THE CENTRAL VENOUS CATHETER WAS BENT AND THAT THERE WAS A THROMBUS IN THE SIDE HOLE. THE PATIENT'S CONDITION WAS CLOSELY MONITORED. SUBSEQUENT COLOR DOPPLER ULTRASOUND EXAMINATION OF THE PATIENT SHOWED NO ABNORMALITIES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256312 ↗
• MalfunctionJan 14, 2026Unraveled Material

  IT WAS REPORTED THAT: "(B)(6) 2025, WHEN THE GUIDEWIRE WAS PULLED OUT, THE SWG WAS FOUND UNRAVELED. THEY CHANGED TO 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 24065745 ↗
• MalfunctionDec 17, 2025Difficult to Remove; Unraveled Material; Physical Resistance/Sticking; Difficult to Remove; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "(B)(6) 2025, WHEN THE ICU DOCTOR AT (B)(6) HOSPITAL AFFILIATED TO (B)(6) UNIVERSITY IMPLANTED THE DEVICE, THE GUIDEWIRE GOT STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE WITHDRAWN. THEREFORE, THE GUIDEWIRE AND PUNCTURE NEEDLE HAD TO BE WITHDRAWN TOGETHER, AND A NEW CATHETER WAS RE-INSERTED FOR CATHETERIZATION. THE CUSTOMER SAID THE SWG UNRAVELED, NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01157 AND 3006425876-2025-01160."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828925 ↗
• MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "AT 9:30 ON (B)(6) 2025, THE CENTRAL VENOUS CATHETER KIT FOR HEMODIALYSIS WAS USED TO CATHETERIZE THE FEMORAL VEIN FOR THE PATIENT, ESTABLISH A BLOOD PURIFICATION PATHWAY, AND PERFORM DFPP TREATMENT. THE CATHETER WAS CHECKED TO BE INTACT BEFORE CATHETERIZATION, AND THE CATHETERIZATION PROCESS WAS SMOOTH; DURING THE PERIOD, THE FEEDBACK FROM THE NURSE ON DUTY WAS THAT THE FLOW RATE WAS SLOW, AND THE INTERVENTION WAS NOT CARRIED OUT BECAUSE THE DFPP TREATMENT REQUIRED HIGH FLOW RATE; AT 19:00 ON (B)(6) 2025, THE CATHTER WAS REMOVED. IT WAS FOUND THAT THE CATHETER WAS KINKED AND THERE WAS THROMBUS IN THE LATERAL HOLE; PRELIMINARY TREATMENT: OBSERVE PATIENT, AND CONDUCT ULTRASOUND EXAMINATION TO OBSERVE FOR SWELLING. CURRENTLY, THERE IS NO ABNORMALITY; THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767215 ↗
• MalfunctionDec 1, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT"(B)(6) 2025, AFTER INSERTION, THE SWG UNRAVEL AFTER INTO THE VESSEL, CHANGED A NEW ONE. THE PATIENT CONDITION IS FINE. NO HARM FOR THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO MEDICAL INTERVENTION WAS REQUIRED. NO MORE OTHER INFORMATION WILL BE REQUIRED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680053 ↗
• MalfunctionNov 5, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: " WHEN THE SWG WAS INSERTED INTO THE VESSEL IT UNRAVELED. ANOTHER SWG WAS USED IN ITS PLACE AND THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474875 ↗
• MalfunctionAug 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, DURING INSERTION, THE DOCTOR FOUND THE SWG DAMAGED." 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 22781840 ↗
• MalfunctionApr 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, "ON (B)(6) 2025, HEMODIALYSIS UNIT, (B)(6) HOSPITAL THE DOCTOR GAVE FEEDBACK THE SWG HAS A QUALITY ISSUE DURING USE ON 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 21805681 ↗
• MalfunctionDec 3, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "A PATIENT CONNECTED TO A FUNCTIONAL 5008 MACHINE IS RECEIVED, WHO FINISHES HIS TREATMENT AFTER 5 MINUTES, CAUSING ALERT IN THE EQUIPMENT, THE LINES ARE REVIEWED AND IT IS IDENTIFIED THAT THEY WERE INVERTED BY DYSFUNCTION OF THE MAHURKAR CATHETER, WHICH CAUSED CONFUSION WHEN CONNECTING THE LINE IN THE EQUIPMENT, THEREFORE THE MACHINE IS ALARMED, THE REVISION IS CARRIED OUT USING THE TWEEZERS, ACCOMMODATION OF THE LINES AND PATENCY OF THE CATHETER, WITH NO RESULTS. THE PATIENT PRESENTED IRRITABILITY FOLLOWED BY TONIC-CLONIC CONVULSION LASTING 40 SECONDS, CAUSING COAGULATION OF THE CIRCUIT AND DIALYZER. VENOUS RETURN IS PERFORMED WITH PHYSIOLOGICAL SOLUTION THAT IS CONNECTED TO THE ALTERNATE INLET OF THE VENOUS LINE, WHICH DOES NOT ALLOW MANUAL RETURN. DIRECT MANEUVERS ARE PERFORMED WITH A SYRINGE AND RESISTANCE OF THE LINES IS PERCEIVED AND IT IS VERIFIED THAT THEY ARE COAGULATED, SO ONLY THE CATHETER IS PERMEABILIZED AND HEPARINIZED. HELP IS REQUESTED, A BLOOD BIOMETRY SAMPLE IS TAKEN, LEVETIRACETAM 230MG IS ADMINISTERED IN TRAVENOUSLY AND THE PATIENT IS LEFT UNDER OBSERVATION FOR 30 MINUTES AND IS DISCHARGED HOME." THE PHYSICIAN DOES NOT ATTRIBUTE THE PATIENT'S TON

  Patient problems: Insufficient Information

  MAUDE report 20831766 ↗
• MalfunctionJul 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "31 MAY 2024, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT. THEY WERE REPORTED AS FINE WITH HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674966 ↗
• MalfunctionMay 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT: " THE PATIENT DEVELOPED AN ALLERGY-LIKE CONDITION (DROWSINESS AND MALAISE) AFTER INSERTION OF THE DEVICE WITH A PRODUCT COATING". THE PATIENT WAS REPORTED AS FINE AFTER THE INCIDENT WITH NO OTHER REPORTED HARM OR CONSEQUENCE.

  Patient problems: Sleepiness/Drowsiness/Somnolence

  MAUDE report 19284606 ↗
• MalfunctionApr 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IT WAS FOUND THAT THE GUIDE WIRE WAS SOMEWHAT BENT WHEN INSERTING A CATHETER INTO A PATIENT AND COULD NOT PASS THROUGH THE CATHETER, MAKING IT UNUSABLE" 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 19060685 ↗
• InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE HEMATOLOGIST INFORMED THE PATIENT THAT AFTER SUCCESSFUL CATHETERIZATION AND HEMOFILTRATION TREATMENT, A FOLLOW-UP ULTRASOUND WAS PLANNED BEFORE EXTUBATION. THE ULTRASOUND SHOWED HYPOECHOIC ATTACHMENT (THROMBOSIS) AROUND THE RIGHT COMMON FEMORAL VEIN AFTER CATHETERIZATION. FOLLOWING ANTICOAGULATION TREATMENT FOR TWO WEEKS, THE PATIENT IS CURRENTLY UNDER OBSERVATION AND TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18928523 ↗
• MalfunctionMar 8, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "SWG UNRAVELED DURING REMOVAL." THE DEVICE WAS REMOVED AND REPLACED. ANOTHER SET WAS USED AND WAS SUCCESSFUL. NO PAITENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN" AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18865130 ↗
• MalfunctionFeb 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737978 ↗
• MalfunctionDec 13, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT"15 NOV 2023, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT. PATIENT REPORTED AS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316823 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597859 ↗
• MalfunctionAug 13, 2023Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED "LUMEN BLOCKAGE" DURING USE. THE USER NOTED RESISTANCE WHEN PLACING THE WIRE THROUGH THE EXTENSION LINE AND AFTER THE CATHETER WAS PLACED THE FLOW WAS NOT SMOOTH. THE DEVICE WAS REPLACED. THE SAME PROBLEM HAPPENED ON THE SECOND CATHETER USED ON THE SAME PATIENT. THEY CHANGED TO A CS-25122-F AND NO FURTHER ISSUE OCCURRED. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538070 ↗
• MalfunctionAug 13, 2023Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED "LUMEN BLOCKAGE" DURING USE. THE USER NOTED RESISTANCE WHEN PLACING THE WIRE THROUGH THE EXTENSION LINE AND AFTER THE CATHETER WAS PLACED THE FLOW WAS NOT SMOOTH. THE DEVICE WAS REPLACED. THE SAME PROBLEM HAPPENED ON THE SECOND CATHETER USED ON THE SAME PATIENT. THEY CHANGED TO A CS-25122-F AND NO FURTHER ISSUE OCCURRED. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538062 ↗
• MalfunctionJul 6, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED RESISTANCE WAS FOUND WHEN THE SPRING WIRE GUIDE WAS INSERTED INTO THE CATHETER. THE SPRING WIRE GUIDE WAS FOUND KINKED DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276185 ↗

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, Classified
  Description/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 · Terminated
  ARROWg+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 · Terminated
  ARROWg+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 · Terminated
  1) 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 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions