ARROW IPN030111Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902100184), received between Aug 6, 2025 and Dec 17, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 17, 2025Difficult to Remove; Material Separation; Unraveled Material; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "ON (B)(6) 2025, WHEN THE ICU DOCTOR AT (B)(6) HOSPITAL AFFILIATED TO (B)(4) IMPLANTED THE DEVICE, THE GUIDEWIRE GOT STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE WITHDRAWN. THEREFORE, THE GUIDEWIRE AND PUNCTURE NEEDLE HAD TO BE WITHDRAWN TOGETHER, AND A NEW CATHETER WAS RE-INSERTED FOR CATHETERIZATION. THE CUSTOMER SAID THE SWG UNRAVELED, NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01157 AND 3006425876-2025-01160.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828818 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED "ON (B)(6), HE BEGAN TO EXPERIENCE SYMPTOMS OF MALAISE, LOSS OF APPETITE, JOINT PAIN, AND GENERALIZED WEAKNESS. IM DEXAMETHASONE + DICLOFENAC WAS ADMINISTERED. TWO DAYS LATER, ON (B)(6), HE BEGAN TO EXPERIENCE DIPLOPIA, HEADACHE, BLURRED VISION, AND GAIT DISTURBANCES, AND HIS PRURITUS WORSENED. ON (B)(6) 2025, HE WAS ADMITTED TO THE ICU FOR MONITORING DUE TO THE RISK OF VENTILATORY DETERIORATION. ON (B)(6) 2025, PLASMAPHERESIS WAS DECIDED, LEADING TO THE INSTALLATION OF A RIGHT FEMORAL MAHURKAR CATHETER. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A SEVERELY ELEVATED LEUKOCYTE COUNT AND NEUTROPHILIA, IN ADDITION TO COMPROMISED KIDNEY FUNCTION. TO RULE OUT AN ONGOING INFECTION, BLOOD CULTURES, A CHEST X-RAY, AND URINALYSIS + GRAM STAIN WERE ORDERED, AND A TEMPERATURE CURVE WAS MONITORED. ANTIBIOTICS WERE NOT STARTED AT THIS TIME DUE TO HEMODYNAMIC STABILITY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: Blurred Vision; Headache; Muscle Weakness/Atrophy; Pain

  MAUDE report 22726658 ↗

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