ARROW IPN030147Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801902100207), received between Jan 27, 2021 and Mar 4, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (29 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Unraveled Material

  IT WAS REPORTED THAT: "ON (B)(6) 2026, DURING CATHETERIZATION IN THE INTENSIVE CARE UNIT OF THE (B)(6) HOSPITAL, IT WAS DISCOVERED THAT THE GUIDEWIRE HAD BECOME UNRAVELED AND COULD NOT BE INSERTED, SO A NEW CATHETER WAS USED INSTEAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505122 ↗
• MalfunctionMar 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, DURING CATHETERIZATION IN THE EMERGENCY INTERNAL MEDICINE DEPARTMENT OF (B)(6) HOSPITAL, IT WAS DISCOVERED THAT THE GUIDEWIRE WAS KINKED. DESPITE ATTEMPTS TO OPERATE, IT COULD NOT BE INSERTED. AFTER CONFIRMED WITH THE CUSTOMER. 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 24504921 ↗
• MalfunctionFeb 20, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2026, DURING INSERTION, THE SWG WAS FOUND KINKED 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 24401049 ↗
• MalfunctionFeb 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2025, THE SWG WAS FOUND KINKED PRIOR TO 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 24302547 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT: " ON (B)(6) 2025, IN ICU (B)(6) SECOND HOSPITAL, DURING INSERTION THE DOCTOR FOUND NEEDLE AND NEEDLE HUB SEPARATED 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972534 ↗
• MalfunctionJan 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "ON (B)(6) 2025, A RESPIRATORY SPECIALIST FROM CHINA-JAPAN FRIENDSHIP HOSPITAL, FOUND THAT THE SWG WAS 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972513 ↗
• MalfunctionJan 6, 2026Complete Blockage

  IT WAS REPORTED THAT: " ON (B)(6) 2025, A RESPIRATORY SPECIALIST FROM (B)(6) HOSPITAL, FOUND THAT CATHETER WAS BLOCKED 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972016 ↗
• MalfunctionDec 31, 2025Unraveled Material; Material Deformation; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT "THE CATHETER UNRAVELED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932417 ↗
• MalfunctionNov 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE CATHETER WAS BLOCKED AFTER ICU CATHETERIZATION. 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 23595536 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE PATIENT WAS REPORTED AS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01067, 3006425876-2025-01068 AND 3006425876-2025-01069."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594024 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE PATIENT WAS REPORTED AS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01067, 3006425876-2025-01068 AND 3006425876-2025-01069."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593948 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593932 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE GUIDE WIRE KINKING. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THE PATIENT WAS REPORTED AS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01067, 3006425876-2025-01068 AND 3006425876-2025-01069."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593837 ↗
• MalfunctionNov 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT "ACCORDING TO THE DOCTOR'S ORDER, RASITOL 100MG WAS ADMINISTERED STAT IV, AND CVC PLACEMENT WAS ASSISTED AS NEEDED BASED ON THE PATIENT'S CONDITION FOR HEMODIALYSIS. DURING THE EMERGENCY PHYSICIAN'S ASSISTANCE IN CATHETER PLACEMENT, IT WAS FOUND THAT THE GUIDE WIRE COULD BE INSERTED INTO THE NEEDLE BUT COULD NOT BE SMOOTHLY REMOVED." 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 23533084 ↗
• MalfunctionJul 9, 2025Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTOR ATTEMPTED TO REMOVE THE GUIDE-WIRE, BUT THE GUIDE-WIRE BECAME DEFORMED; THE WIRE BECAME THINNER, BENT, AND ELONGATED". 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 22457373 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR OPENED THE PACKAGE AND FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436549 ↗
• MalfunctionJun 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "SWG BENT." 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 22309212 ↗
• MalfunctionApr 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND SWG KINKED WHEN OPENING THE PACKAGE PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 21832636 ↗
• MalfunctionApr 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, EMERGENCY ICU, (B)(6) HOSPITAL, THE DOCTOR FOUND THE SWG REMOVE IS DIFFICULT AFTER INSERTION. AFTER THAT HE FOUND THE SWG KINKED DURING USE ON THE SAME PATIENT. IT HAPPENED IN TWO CONSECUTIVE CASES." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00361 .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825456 ↗
• MalfunctionApr 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, EMERGENCY ICU, (B)(6) HOSPITAL, THE DOCTOR FOUND THE SWG REMOVE IS DIFFICULT AFTER INSERTION. AFTER THAT HE FOUND THE SWG KINKED DURING USE ON THE SAME PATIENT. IT HAPPENED IN TWO CONSECUTIVE CASES." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00374.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825431 ↗
• MalfunctionMar 26, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CATHETER BLOCK 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 21698148 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "THE DOCTOR FOUND THAT THE CONNECTOR FROM HOSPITAL WAS SEPARATED IN THE LUER HUB 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 21457283 ↗
• MalfunctionFeb 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG CAN'T INSERTED INTO ARS DURING USED ON THE PATIENT. SWG WAS FOUND KINKED. 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 21433000 ↗
• MalfunctionJan 6, 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. THE PATIENT HAD NO HARM. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079296 ↗
• MalfunctionDec 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE PHYSICIAN FOUND THE ARS/SWG RESISTANCE PRIOR TO THE PATIENT. THE SWG WAS FOUND KINKED. THE PATIENT HAD NO HARM. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE". THE PATIENT CONDITION IS FINE, AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986118 ↗

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