ARROW IPN033168Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902100597), received between Aug 11, 2023 and Jul 7, 2025 — classified as 1 injury, 3 malfunctions.

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

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

• MalfunctionJul 7, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED "COPIOUS OOZING NOTED FROM A-LINE SITE DURING DRESSING CHANGE. ASSESSMENT REVEALED THE A-LINE CATHETER WAS DAMAGED AND NEEDED TO BE REPLACED. A SMALL PIECE OF THE CATHETER WAS BROKEN." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413931 ↗
• InjuryMar 4, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT: CLINICIAN WAS ATTEMPTING TO INSERT ARTERIAL CATHETER HOWEVER ENCOUNTERED TROUBLE WITH CHALLENGING ACCESS. WHEN DEVICE WAS INSPECTED, IT WAS OBSERVED THAT A FRAGMENT OF THE CATHETER REMAINED IN THE PATIENT. ADDITIONAL INFORMATION: RESISTANCE WAS MET WHEN ATTEMPTING TO ADVANCE THE CATHETER. THE FRAGMENT OF THE SWG WAS FULLY REMOVED WITH SURGICAL INTERVENTION. THE PATIENT WAS CODING AT THE TIME OF THE INSERTION ATTEMPT. THEY ARE IN ICU AT PRESENT BECAUSE OF THEIR UNDERLYING CONDITION. THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE SWG SEPARATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18824692 ↗
• MalfunctionFeb 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "SWG KINKING." THE ISSUE WAS IDENTIFIED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635022 ↗
• MalfunctionAug 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "UNPACK THE PACKAGE, THE GUIDE WIRE WAS KINKING." NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511101 ↗

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-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• 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-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• 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-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-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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018

…and 17 more.