ARROW IPN036993Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902117813), received between Jul 27, 2021 and Feb 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Fluid/Blood Leak; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: "THE RA-04020 CATHETER WITHIN KIT, WAS PLACED IN THE OPERATING ROOM ON (B)(6) 2022, WITH NO COMPLICATIONS. 2 DAYS LATER, RESPIRATORY THERAPY WAS ASKED TO ASSESS FAILED/FAILING ARTERIAL LINE, WITH REPORT THAT IT LEAKED DURING FLUSHING. ALSO NOTED POOR WAVEFORM, WITHOUT PRESSURE READING. ATTEMPTED TO DRAW BLOOD & NOTICED A SMALL AMOUNT OF BLOOD LEAKING AT PUNCTURE SITE. REMOVED DRESSING AND NOTED THAT CATHETER WAS KINKED AT HUB. WITHDREW CATHETER SLIGHTLY TO EXAMINE FURTHER, AND NOTED ANOTHER KINK APPROXIMATELY 1/2 CM DISTAL TO THE FIRST KINK. BLOOD OOZING FROM KINK AT HUB. ATTEMPTED TO FLUSH USING PIGTAIL, AND OBSERVED CLEAR FLUID SPRAYING FROM SIDE OF CATHETER AT KINK. WHEN FLUSHING STOPPED, BLOOD AGAIN OOZED FROM CATHETER. CATHETER WAS IMMEDIATELY REMOVED AND REPLACED WITHOUT ISSUE." NO PATIENT INJURY WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382816 ↗
• MalfunctionJul 27, 2021Unraveled Material; Unraveled Material

  CLINICIAN NOTICED INTEGRAL GUIDE WIRE WAS DISTORTED UPON REMOVING NEEDLE/WIRE FROM THE CATHETER AFTER PLACEMENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228081 ↗

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-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• 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-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• 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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• 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.