ARROW IPN032968Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902096166), received between Jan 14, 2026 and Jan 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Unraveled Material

  IT WAS REPORTED THAT: "DURING PLACEMENT OF A VASCATH FOR PATIENT NEEDING DIALYSIS IN THE MSICU, IT WAS DETECTED BY THE OPERATOR THAT THE CATHETER WOULD NOT PASS OVER THE GUIDEWIRE. WHEN THE WIRE WAS REMOVED IT WAS BENT AND UNRAVELING. THEY OBTAINED A SECOND KIT AND IT RECURRED". ASSOCIATED OMPLAINTS: 9680794-2026-00068 AND 9680794-2026-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065952 ↗
• MalfunctionJan 14, 2026Unraveled Material

  IT WAS REPORTED THAT: "DURING PLACEMENT OF A VASCATH FOR PATIENT NEEDING DIALYSIS IN THE MSICU, IT WAS DETECTED BY THE OPERATOR THAT THE CATHETER WOULD NOT PASS OVER THE GUIDEWIRE. WHEN THE WIRE WAS REMOVED IT WAS BENT AND UNRAVELING. THEY OBTAINED A SECOND KIT AND IT RECURRED". ASSOCIATED OMPLAINTS: 9680794-2026-00068 AND 9680794-2026-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065946 ↗

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