ARROW IPN925079Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902210620), received between Jun 25, 2026 and Sep 30, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948261 ↗
• MalfunctionSep 30, 2026Stretched; Detachment of Device or Device Component

  Provider placed an arterial line at bedside. During the procedure, when retracting the wire, the wire stretched and stripped out of the catheter. X-ray ordered post-procedure. After obtaining x-ray part of the needle remained in the A-line catheter in the patient's arm. A-line discontinued at this time. Vascular consulted. The patient will have to go to surgery for retrieval.

  Patient problems: Foreign Body In Patient

  MAUDE report 50945230 ↗
• MalfunctionSep 29, 2026Material Twisted/Bent; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937334 ↗
• MalfunctionSep 21, 2026Material Twisted/Bent; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840482 ↗
• MalfunctionSep 2, 2026Device Damaged Prior to Use; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555350 ↗
• MalfunctionAug 11, 2026Material Separation

  Patient problems: Insufficient Information

  MAUDE report 50204011 ↗
• MalfunctionJul 29, 2026Fracture; Unraveled Material; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073074 ↗
• MalfunctionJun 25, 2026Material Separation; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, THE SPRING WIRE GUIDE (SWG) UNCOILED UPON ATTEMPTED RETRACTION. DURING THIS PROCESS, A FRAGMENT SEPARATED FROM THE SWG AND WAS IDENTIFIED SUBCUTANEOUSLY IN THE PATIENT. ADDITIONAL INFORMATION INDICATED THAT THE OPERATING PHYSICIAN EXPERIENCED DIFFICULTY RETRACTING THE SWG DURING INSERTION. AN ULTRASOUND EXAMINATION WAS PERFORMED, WHICH CONFIRMED THAT THE SEPARATED FRAGMENT WAS NOT LOCATED WITHIN THE ARTERIAL VESSEL. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627959 ↗

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-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• 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-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• 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-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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120

…and 17 more.