ARROW IPN033170Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902100603), received between Mar 12, 2021 and Apr 1, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "AFTER INSERTING THE INTRODUCER NEEDLE INTO THE ARTERY, THE USER WAS UNABLE TO ADVANCE THE SWG INTO IT SMOOTHLY. THEREFORE, THE NEEDLE AND THE SWG WERE REMOVED AND REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED. IT IS UNKNOWN AT PRESENT IF THE SWG WAS KINKED OR DAMAGED AT PRESENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737991 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE ARTERIAL LINE DRESSING WAS SOAKED WITH BLOOD, AND IT APPEARED THAT THERE IS A SPLIT IN THE CATHETER. THE LINE WAS REMOVED FROM THE PATIENT AND QUARANTINED.".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21731003 ↗
• MalfunctionFeb 12, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE WON'T PASS THROUGH THE NEEDLE. ADDITIONAL INFORMATION: THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT. THE WIRE WAS RETURNED FOR INVESTIGATION AND THE ENGINEERS NOTED THAT IT WAS KINKED. ASSOCIATED TO 9680794-2024-00104, 9680794-2024-00105, 9680794-2024-00106 AND 9680794-2024-00107.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685275 ↗
• MalfunctionFeb 1, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE WON'T PASS THROUGH THE NEEDLE. ADDITIONAL INFORMATION: THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT. THE WIRE WAS RETURNED FOR INVESTIGATION AND THE ENGINEERS NOTED THAT IT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622011 ↗
• MalfunctionFeb 1, 2024Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE WON'T PASS THROUGH THE NEEDLE. ADDITIONAL INFORMATION: THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT. THE WIRE WAS RETURNED FOR INVESTIGATION AND THE ENGINEERS NOTED THAT IT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621962 ↗
• MalfunctionFeb 1, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE WON'T PASS THROUGH THE NEEDLE. ADDITIONAL INFORMATION: THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT. THE WIRE WAS RETURNED FOR INVESTIGATION AND THE ENGINEERS NOTED THAT IT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621843 ↗
• MalfunctionFeb 1, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE WON'T PASS THROUGH THE NEEDLE. ADDITIONAL INFORMATION: THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT. THE WIRE WAS RETURNED FOR INVESTIGATION AND THE ENGINEERS NOTED THAT IT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621779 ↗
• MalfunctionMay 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE CATHETER DURING USE ON RADIAL ARTERY. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11896267 ↗
• MalfunctionMar 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE COMPLAINT IS REPORTED AS: "TWO CATHETERS DEVELOPED HOLES AFTER SEVERAL DAYS OF DWELL." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475365 ↗
• MalfunctionMar 12, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE COMPLAINT IS REPORTED AS: "TWO CATHETERS DEVELOPED HOLES AFTER SEVERAL DAYS OF DWELL." NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475320 ↗

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-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-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-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• 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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• 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

…and 17 more.