ARROW IPN030157Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902009217), received between Feb 28, 2023 and Feb 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• InjuryFeb 28, 2023Air/Gas in Device; Air/Gas in Device

  CUSTOMER COMPLAINT IS REPORTED AS: "A COUPLE OF WEEKS AGO, WE HAD A PATIENT SUFFER AN AIR EMBOLISM JUST AFTER STANDING UP WITH A RENAL REPLACEMENT CIRCUIT CONNECTED TO A 20CM ARROWGARD LINE. AIR WAS SEEN TO BE BEING DRAGGED FROM THE PATIENT ROUND THE CIRCUIT. THE LINE WAS POSITIONED VERY CLOSE TO A VYGON CENTRAL LINE. THE INSERTION SITE WAS NECK. BOTH WERE REMOVED & EXAMINED. THERE WAS NO EVIDENCE OF AIR LEAK WHEN THEY WERE INJECTED WITH AIR AFTER BEING SUBMERSED IN WATER AND NO EVIDENCE OF A LEAK WHEN FLUSHED WITH SALINE. THE EASIEST EXPLANATION IS PERHAPS THAT THE LINE WAS MOVED DURING MOBILISATION BUT THE PEOPLE WHO WERE THERE SAY THAT THIS DIDN'T HAPPEN. THE PATIENT DID HAVE A BRIEF PERIOD OF DETERIORATION BUT RECOVERED QUITE QUICKLY WITH NO ILL EFFECTS AND HAS BEEN DISCHARGED FROM ICU".

  Patient problems: Air Embolism

  MAUDE report 16452398 ↗

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