ARROW IPN037063Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20801902121534), received between Oct 19, 2021 and Jun 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "OUR NIGHT SHIFT PA ON THE INTENSIVIST TEAM ATTEMPTED TO START AN A- LINE WITH THIS RADIAL ARTERY KIT. YOU CAN SEE THE CURVE THAT HAPPENED AT THE TIP OF THE CATHETER WHEN SHE ATTEMPTED TO ADVANCE. SHE SAID THAT THIS WAS THE SECOND TIME THIS HAS HAPPENED TO HER IN THE RECENT MONTH." A NEW CATHETER WAS PLACED IN THE OPPOSITE ARM. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00463 AND 9680794-2025-00455.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143577 ↗
• MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "OUR NIGHT SHIFT PA ON THE INTENSIVIST TEAM ATTEMPTED TO START AN A- LINE WITH THIS RADIAL ARTERY KIT. YOU CAN SEE THE CURVE THAT HAPPENED AT THE TIP OF THE CATHETER WHEN SHE ATTEMPTED TO ADVANCE. SHE SAID THAT THIS WAS THE SECOND TIME THIS HAS HAPPENED TO HER IN THE RECENT MONTH." A NEW CATHETER WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00463 AND 9680794-2025-00455.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143490 ↗
• MalfunctionOct 19, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: RESPIRATORY THERAPIST AT BEDSIDE TO INSERT ARTERIAL ONTO RIGHT RADIUS. REPORTS THAT ONCE INSERTED THE ARTERIAL LINE WOULDN'T READ SO THEY REMOVED CATHETER. UPON REMOVAL IT WAS NOTED THAT APPROXIMATELY 2 CENTIMETERS OF THE PLASTIC TIP WAS MISSING. ED RESIDENT DID PERFORM BEDSIDE US (ULTRASOUND) TO SEE IF FOREIGN BODY COULD BE IDENTIFIED , NOTHING NOTED ON US. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656533 ↗

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-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• 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-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• 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-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
• 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

…and 17 more.