ARROW IPN036717Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902123504), received between Dec 20, 2024 and Dec 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PRE-INSERTION SETUP, THE INSERTING CLINICIAN OPENED THE FIRST KIT AND OBSERVED A KINK IN THE DISTAL TUBING/LUMEN. THE FIRST CATHETER/KIT WAS REMOVED, AND A SECOND CATHETER/KIT FROM THE SAME ITEM/LOT WAS OPENED. THE SECOND CATHETER HAD THE SAME KINK AS THE FIRST; HOWEVER, DUE TO THE EMERGENT NATURE OF THE PROCEDURE, THE INSERTING CLINICIAN PROCEEDED TO INSERT IT INTO THE PATIENT. THE SECOND CATHETER, WAS PLACED, DID FUNCTION WELL DURING USE & DID NOT CAUSE ANY ISSUE. THERE WAS A SLIGHT DELAY IN THERAPY AS ADDITIONAL TIME WAS REQUIRED TO GRAB THE SECOND KIT FROM INVENTORY. THE PATIENT CONDITION WAS REPORTED AS "FINE," WITH NO PATIENT INJURY, CONSEQUENCE, OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986672 ↗

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