ARROW IPN036982Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902119855), received between Mar 19, 2021 and Feb 4, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

31 other recalls cover devices cleared under the same FDA submission (K810675); 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-2397-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "UPON REMOVAL OF WIRE, THE WIRE BECAME STUCK AND THEN BROKE". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303673 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: THE USER UTILIZED THE CATHETER OVER NEEDLE IN THIS KIT AS AN ARTERIAL LINE AND THE CATHETER STARTED LEAKING AT THE HUB. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546957 ↗
• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: THE USER UTILIZED THE CATHETER OVER NEEDLE IN THIS KIT AS AN ARTERIAL LINE AND THE CATHETER STARTED LEAKING AT THE HUB. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546854 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE HUB OF THE CATHETER IS LEAKING WHEN FLUSHED. IT WAS REPORTED THE CATHETER OVER INTRODUCER NEEDLE WAS BEING USED AS THE INDWELLING CATHETER AND THIS IS WHAT WAS LEAKING. THE CATHETER WAS STILL IN THE PATIENT AT THE TIME OF THIS REPORT AS THE CUSTOMER DID NOT FEEL THE PATIENT WAS AT RISK FOR HARM. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810675. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
• Z-0844-2020 · Dec 12, 2019 · Open, Classified
  Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1330-2018 · Dec 22, 2017 · Terminated
  (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Fea
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220

…and 16 more.