ARROW IPN036478Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30801902117374), received between Aug 28, 2023 and Feb 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT: ER DOCTOR WAS PLACING AN EMERGENT FEMORAL ARTERIAL LINE AS PATIENT WAS CRITICALLY ILL AND THEY WERE UNABLE TO OBTAIN BLOOD PRESSURE READING. IT WAS A NON-STERILE PROCEDURE AS THE PATIENT LOOKED LIKE THEY MAY CODE. ULTRASOUND GUIDANCE WAS USED. THE DOCTOR TESTED THE WIRE THROUGH THE NEEDLE, AND IT WAS SMOOTH BEFORE THE PROCEDURE. THE ARTERIAL STICK WAS SUCCESSFUL BUT WHEN THEY ATTEMPTED TO TREAD THE WIRE THROUGH THE NEEDLE INTO THE PATIENT, SHE MET RESISTANCE. SHE ATTEMPTED TO PULL BACK THE WIRE BUT MET RESISTANCE AGAIN. SHE MANAGED TO REMOVE THE WIRE BUT FOUND THAT IT WAS UNCOILED, AND A PIECE WAS SEPARATED. THE ULTRASOUND SHOWED THAT THE END OF THE WIRE WAS IN THE PATIENT'S SOFT TISSUE ON TOP OF THE ARTERY. A CTA WAS DONE BECAUSE OF THE PATIENT'S CONDITION, AND THIS CONFIRMED THAT THE WIRE WAS NOT IN THE VASCULATURE. THE WIRE WAS LEFT IN PLACE ON THE ADVICE OF VASCULAR SURGICAL DOCTOR AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL BECAUSE OF THEIR CRITICAL CONDITION. IT WAS HANDED OVER THAT THE PATIENT HAD THE PIECE OF WIRE IN SITU, BUT THE TEAM ARE NOT AWARE OF WHAT HAPPED AFTER THIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18766055 ↗
• MalfunctionAug 28, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE GUIDEWIRE WAS BENT WHEN THE KIT WAS OPENED. ANOTHER KIT WAS OBTAINED FOR USE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630766 ↗
• MalfunctionAug 28, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE GUIDEWIRE WAS BENT WHEN THE KIT WAS OPENED. ANOTHER KIT WAS OBTAINED FOR USE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630722 ↗

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-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-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-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• 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-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-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020

…and 17 more.