ARROW IPN036723Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30801902123597), received between Feb 7, 2025 and Nov 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2373-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2372-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionNov 28, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT "NO TIP ON DILATOR. TIP OF THE DILATOR WAS MISSING. PATIENT WAS NOT HARMED AND IN STABLE CONDITION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670771 ↗
• InjuryFeb 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A GUIDEWIRE WAS FOUND HANGING OUT FROM THE DISTAL LUMEN OF THE CATHETER. THE ISSUE WAS IDENTIFIED ON AN X-RAY POST INSERTION. THE GUIDEWIRE APPEARED TO HAVE SHEARED. AS A RESULT, THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR), AND THE GUIDEWIRE WAS SUCCESSFULLY REMOVED. ADDITIONAL INFORMATION FROM THE CLINICAL STAFF INDICATED THAT THE PATIENT LATER PASSED AWAY; HOWEVER, THE DEATH WAS UNRELATED TO THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21333630 ↗

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-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