ARROW IPN919779Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902191165), received between Apr 7, 2023 and Apr 14, 2026 — classified as 4 malfunctions.

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

• MalfunctionApr 14, 2026Material Twisted/Bent

  IT WAS REPORTED THAT"(B)(6) 2026, IN ICU, BEFORE INSERTION, THE TIP OF SWG WAS FOUND KINKED PRIOR TO THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869403 ↗
• MalfunctionApr 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2026, IN ICU, DURING THE INSERTION, THE SWG WAS FOUND KINKED WHILE INSERTING INTO THE CATHETER DURING USE ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843190 ↗
• MalfunctionApr 2, 2026Obstruction of Flow

  IT WAS REPORTED THAT: "(B)(6) 2026, IN THE HEMODIALYSIS UNIT, INSUFFICIENT BLOOD FLOW OCCURRED WITHIN LESS THAN TWO WEEKS AFTER CATHE TER INSERTION." THERE WAS NO REPORTED PATIENT HARM. A NEW DEVICE WAS INSERTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765324 ↗
• MalfunctionApr 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2023, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT. NO SAMPLE WILL BE RETURNED. NO PHOTO IS AVAILABLE." PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701467 ↗

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