ARROW IPN030156Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902100221), received between Oct 18, 2023 and Sep 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "SWG BENT." THE DEVICE WAS REPLACED. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063032 ↗
• MalfunctionJun 13, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED " DURING DYALISE CATHETER INSERTION, THE GUIDE WAS BLOCKED IN THE TROCAR. ONE OF THE 2 GUIDE IS UNRAVELLED AND DAMAGED." THE PATIENT'S CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS WAS ASKED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22201443 ↗
• MalfunctionApr 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "SWG KINKING, DIFFICULT TO ADVANCE, SO CANNOT USED TO COMPLETE THE PROCEDURE." NO PATIENT HARM OR INJURY. NO DELAY TO THERAPY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200650 ↗
• MalfunctionOct 18, 2023Device Slipped; Detachment of Device or Device Component; Infusion or Flow Problem; Migration; Device Slipped; Detachment of Device or Device Component; Infusion or Flow Problem; Migration

  IT WAS REPORTED THAT: THE LINE WAS STITCHED IN - IT SLIPPED THROUGH THE HOLDER, HAPPENED TWICE ON 1 PATIENT (2ND DEVICE ASSOCIATED TO THIS COMPLAINT), THERE WAS A PREVIOUS ISSUE THE WEEK BEFORE, - UNWELL LADY WITH HIGH INOTROPE REQUIREMENTS LEADING TO A DELAY IN CONTINUING HER CVVHD - THE LINE WAS PROMPTLY REPLACED. (ASSOCIATED TO 2 OTHER COMPLAINTS TC# (B)(4) AND TC# (B)(4)). THE PATIENT'S CONDITION DID NOT DETERIORATE DUE TO IMMEDIATE REPLACEMENT OF LINE, THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956383 ↗
• MalfunctionOct 18, 2023Migration; Migration

  IT WAS REPORTED THAT: THE LINE WAS STITCHED IN - IT SLIPPED THROUGH THE HOLDER,(ASSOCIATED (B)(4)) HAPPENED TWICE ON 1 PATIENT (ASSOCIATED TO (B)(4)), THERE WAS AN ISSUE THE WEEK BEFORE, (ASSOCIATED THIS COMPLAINT). THE PATIENT'S CONDITION DID NOT DETERIORATE DUE TO IMMEDIATE REPLACEMENT OF LINE, THE PATIENT WAS NOT HARMED.

  Patient problems: Insufficient Information

  MAUDE report 17955734 ↗
• MalfunctionOct 18, 2023Device Slipped; Detachment of Device or Device Component; Infusion or Flow Problem; Migration; Device Slipped; Detachment of Device or Device Component; Infusion or Flow Problem; Migration

  IT WAS REPORTED THAT: THE LINE WAS STITCHED IN - IT SLIPPED THROUGH THE HOLDER , (ASSOCIATED TO THIS COMPLAINT) HAPPENED TWICE ON 1 PATIENT, THERE WAS A PREVIOUS ISSUE THE WEEK BEFORE , (ASSOCIATED TO 2 OTHER COMPLAINTS TC# (B)(4)) - UNWELL LADY WITH HIGH INOTROPE REQUIREMENTS LEADING TO A DELAY IN CONTINUING HER CVVHD - THE LINE WAS PROMPTLY REPLACED. THE PATIENT'S CONDITION DID NOT DETERIORATE DUE TO IMMEDIATE REPLACEMENT OF LINE, THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955701 ↗

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