ARROW IPN035502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902068002), received between Jun 24, 2021 and Jun 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionJun 24, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: GUIDEWIRE INSERTED SMOOTHLY AND AFTER 10CM IT WOULD NOT ADVANCE FURTHER SO THEY ATTEMPTED TO REMOVE THE GUIDEWIRE BUT IT GOT STUCK IN THE INTRODUCER. THE GUIDEWIRE WAS KINKED AND BROKEN. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12061586 ↗
• MalfunctionJun 24, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: GUIDEWIRE INSERTED SMOOTHLY AND AFTER 10CM IT WOULD NOT ADVANCE FURTHER SO THEY ATTEMPTED TO REMOVE THE GUIDEWIRE BUT IT GOT STUCK IN THE INTRODUCER. THE GUIDEWIRE WAS KINKED AND BROKEN. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT MEDICAL INTERVENTION WAS NOT NECESSARY AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061496 ↗

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