ARROW IPN036227Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10801902122503), received between Mar 12, 2021 and Apr 8, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE BENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815651 ↗
• MalfunctionApr 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE BENT". THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815245 ↗
• MalfunctionApr 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "DURING USE, THE TIP OF THE NEEDLE REBOUNDS." THE DEVICE WAS REMOVED AND ANOTHER SET WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847282 ↗
• MalfunctionApr 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "DURING USE, THE TIP OF THE NEEDLE REBOUNDS." THE DEVICE WAS REMOVED AND ANOTHER SET WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847244 ↗
• MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "UPON PULLING OUT, THE SWG WAS FOUND TO BE BENT." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21771851 ↗
• MalfunctionSep 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "IT WAS FOUND ABNORMAL BEND WHEN THE GUIDE WIRE WAS PULLED OUT." ASSOCIATED COMPLAINTS .AND 9680794-2024-00956.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320259 ↗
• MalfunctionSep 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "IT WAS FOUND ABNORMAL BEND WHEN THE GUIDE WIRE WAS PULLED OUT." ASSOCIATED COMPLAINT 9680794-2024-00965.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320242 ↗
• MalfunctionMay 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "SWG KINKED. THE ISSUE WAS IDENTIFIED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339219 ↗
• MalfunctionNov 29, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: THE SWG WAS FOUND TO BE KINKED WHEN REMOVED FROM THE PACK. ANOTHER SWG WAS USED FOR THE PROCEDURE. PRIOR TO USE, NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226280 ↗
• MalfunctionNov 21, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHILE ADVANCING THE SWG INTO THE VESSEL, THE SWG KINKED. AS A RESULT, A NEW KIT WAS USED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183429 ↗
• MalfunctionApr 14, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE SPRING WIRE GUIDE IS KINKED DURING USE.NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668600 ↗
• MalfunctionMar 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: THE SPRING WIRE GUIDE WAS KINKING. ANOTHER SPRING WIRE GUIDE WAS OPENED FOR USE AND ALSO FOUND TO BE KINKING. THE DEVICE WAS REPLACED. NO PATIENT HARM OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569035 ↗
• MalfunctionMar 12, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE SPRING WIRE GUIDE IS "KINKED WHEN PULLING OUT". NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476381 ↗
• MalfunctionMar 12, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE SPRING WIRE GUIDE IS "KINKED WHEN PULLING OUT". NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476377 ↗