ARROW IPN036983Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902117585), received between Sep 6, 2023 and Sep 29, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

30 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-2397-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Jul 26, 2024Open, Classified

   Reports have been received regarding open seals on the packaging.

   Z-3299-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionSep 29, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED A-LINE EXTENSION TUBING SPONTANEOUSLY CRACKED AT THE HUB WHILE CONNECTED TO THE PATIENT AND LEAKED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848045 ↗
• MalfunctionSep 26, 2023Disconnection; Material Deformation; Disconnection; Material Deformation

  IT WAS REPORTED THAT: TUBING DISCONNECTED FROM THE HUB OF THE ARTERIAL LINE DURING USE ON PATIENT. WHEN AN ATTEMPT WAS MADE TO TWIST THE LINE BACK ONTO THE HUB IT WAS NOTED THAT THERE WAS A DEFECT, AND THEY WERE UNABLE TO ATTACH. THE PATIENT WAS REPORTED AS FINE AND THERE WAS NO HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815545 ↗
• MalfunctionSep 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE EXTENSION TUBING SEPARATED WHERE THE TUBING CONNECTS WITH THE LUER LOCK. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT. THE PATIENT WAS REPORTED AS FINE. THERE WAS NO PATIENT HARM. A NEW DEVICE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815521 ↗
• MalfunctionSep 25, 2023Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "PT ARRIVED FROM OR WITH ALINE. ARTERIAL WAVEFORM WENT FLAT, ALARMED ON MONITOR WHICH MADE RN GO INTO ROOM AND CHECK ALINE AFTER CHECKING LOC ON PATIENT. RN FOUND ALINE EXTENSION TUBING BROKE FROM ANGIOCATH AND A PART OF TUBING WAS STUCK IN ANGIOCATH. TEAM ULTIMATELY D/C'D ALINE BECAUSE COULD NOT REMOVE BROKEN PIECE OF TUBING. TUBING SAVED." THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807604 ↗
• MalfunctionSep 7, 2023Material Separation; Material Separation

  CUSTOMER REPORTED "A-LINE TUBE SEVERED BETWEEN TUBING AND CLAVE CONNECTED TO PATIENT. PRESSURE APPLIED TO SITE TO STOP BLEEDING." THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702487 ↗
• MalfunctionSep 6, 2023Material Separation; Material Separation

  CUSTOMER REPORTED "THIS WAS A SEVERED ARTERIAL LINE. THE ARTERIAL LINE WAS PLACED IN THE OPERATING ROOM AND BECAME SEVERED IN ROOM ON (B)(6) 2023 AT 00:30." THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691745 ↗

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-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-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-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-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-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
• 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-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-0486-2018 · Jul 10, 2017 · Terminated
  Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

…and 15 more.