ARROW IPN030210Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902100269), received between Jun 26, 2023 and Apr 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Leak/Splash; Material Deformation

  IT WAS REPORTED THAT: "ON (B)(6) 2026, THE SHAPE OF THE LUER HUB IS INCORRECT. CAUSING A LEAK. THE ISSUE WAS IDENTIFIED DURING USE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873523 ↗
• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, IN ICU BEFORE INSERTION, THE SWG WAS FOUND 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 21976778 ↗
• MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, DURING INSERTION, THE DOCTOR FOUND THE SWG KINKED WHEN PULLING OUT FROM THE ARS." 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 21771899 ↗
• MalfunctionNov 1, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG UNRAVELED DURING USED ON THE PATIENT." ADDITIONAL INFORMATION RECEIVED REPORTS "THE SWG WAS FOUND UNRAVELED WHEN THE SWG WAS REMOVED FROM THE ARS." THE DEVICE WAS REMOVED AND REPLACED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585607 ↗
• MalfunctionSep 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE SWG / ARS RESISTANCE DURING USE ON THE PATIENT. INVOLVED 1 PC. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT CONDITION IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198091 ↗
• MalfunctionMar 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE DOCTOR FOUND THE DILATOR TIP DAMAGED DURING USED ON THE PATIENT." 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 18978008 ↗
• MalfunctionJan 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT"06 DEC 2023, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433789 ↗
• MalfunctionAug 10, 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 17498613 ↗
• MalfunctionJun 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED 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 17197790 ↗

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