ARROW IPN037160Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20801902121572), received between Jul 1, 2019 and Apr 8, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 reports).

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

32 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-2368-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022Material Separation; Material Separation

  COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "GUIDEWIRE WAS PUSHED THROUGH THE CATHETER AND NEEDLE; CATHETER SEPARATED AND BECAME STUCK IN PT'S ARTERY. CATHETER HAD TO BE REMOVED WITH HEMOSTATS; FOUND TO BE FRAYED."

  Patient problems: Foreign Body In Patient

  MAUDE report 14058221 ↗
• MalfunctionFeb 16, 2022Material Frayed; Material Separation; Physical Resistance/Sticking

  GUIDEWIRE WAS PUSHED THROUGH THE CATHETER AND NEEDLE; CATHETER SEPARATED AND BECAME STUCK IN PT'S ARTERY. CATHETER HAD TO BE REMOVED WITH HEMOSTATS; FOUND TO BE FRAYED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13549447 ↗
• MalfunctionDec 28, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "THE GUIDEWIRE KINKED CAUSING THE NEED TO PERFORATE THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE CRITICAL PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098488 ↗
• MalfunctionMay 11, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED "KINKED WIRE BUT BLOOD RETURN." NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809269 ↗
• MalfunctionMay 11, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED "KINKED WIRE BUT NO BLOOD RETURN". NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809262 ↗
• MalfunctionMay 11, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED "KINKED WIRE BUT BLOOD RETURN." NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809199 ↗
• InjuryJul 1, 2019Break; Detachment of Device or Device Component

  RADIAL ARTREY CATH BROKE OFF IN PATIENT DURING INSERTION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8757478 ↗

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-2397-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18
• 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-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• 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-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-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
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120

…and 17 more.