ARROW IPN033172Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902100610), received between Apr 16, 2021 and Jun 25, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED "THEY NOTICE ACTIVE BLEEDING IN THE INSERTION POINT. WHEN TESTING CATHETER THEY NOTICED IT IS BROKEN. THEY HAD TO PUT IT AWAY. A NEW CATHETER IS NEEDED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19608359 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "VERY FLEXIBLE MATERIAL OF THE CATHETER IT BENDS WHEN INSERTING". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL I NTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608315 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "VERY FLEXIBLE MATERIAL. DOES NOT ALLOW A PERMANENT USE OF IT. ITS NEEDED TO USE MULTIPLE CATHETERS AND EXCHANGING IT WITH MORE FREQUENCE". THERE WAS NO PATIENT HARM OR INJURY. NO DELAY TO THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606629 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "VERY FLEXIBLE MATERIAL. DOES NOT ALLOW A PERMANENT USE OF IT. ITS NEEDED TO USE MULTIPLE CATHETERS AND EXCHANGING IT WITH MORE FREQUENCE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606275 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LEAKAGE OF THE CATHETER AFTER STARTING BLOOD PRESSURE MEASURING". THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED. 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 19059831 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  THE SPRING WIRE GUIDE LOOKED BENT UPON OPENING THE CATHETER, PRIOR TO PATIENT USE. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681909 ↗

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-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-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• 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-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-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120

…and 17 more.