ARROW IPN928040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902215137), received between May 14, 2024 and Jul 16, 2025 — classified as 1 injury, 6 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K021120); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED "1ST ATTEMPT AT RADIAL ARTERIAL ACCESS UNDER ULTRASOUND WITH GOOD FLASH, WIRED EASILY, THEN AS WIRE APPARATUS REMOVED FROM CATHETER, THE CATHETER BECAME DAMAGED CLOSE TO THE HUB. THE END OF THE WIRE WAS NOTED TO BE SHREDDED AND UNCOILED. AFTER CATHETER REMOVED (WITH FORMATION OF SMALL HEMATOMA), A 1CM PIECE OF SOLID WIRE FRAGMENT WAS EMBEDDED IN SKIN AND REMOVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 22523322 ↗
• MalfunctionMay 15, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT: " WE HAD A CATHETER TODAY WHERE THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. SIGNIFICANT DAMAGE TO WIRE AND CATHETER NOTED ON REMOVAL". A RETURNED PHOTO SHOWS THAT THE CATHETER IS SEPARATED. 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 19321211 ↗
• MalfunctionMay 15, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. SIGNIFICANT DAMAGE TO WIRE AND CATHETER NOTED ON REMOVAL. A PHOT SHOWED THAT THE CATHETER WAS KINKED. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19321007 ↗
• MalfunctionMay 15, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. SIGNIFICANT DAMAGE TO WIRE AND CATHETER NOTED ON REMOVAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320794 ↗
• MalfunctionMay 15, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "WE HAD A CATHETER TODAY WHERE THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. SIGNIFICANT DAMAGE TO WIRE AND CATHETER NOTED ON REMOVAL". 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 19320639 ↗
• MalfunctionMay 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. THE WIRE WAS REMOVED HOWEVER A PORTION OF THE CATHETER REMAINED WITHIN THE PATIENT". NO PATIENT HARM OR INJURY. A VASCULAR SURGEON WAS CALLED TO FULLY REMOVE THE RETAINED CATHETER. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00449.

  Patient problems: Foreign Body In Patient

  MAUDE report 19311194 ↗
• InjuryMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE WIRE ADVANCED EASILY, BUT THE CATHETER ONLY ADVANCED PART WAY, AFTER WHICH BOTH THE WIRE AND CATHETER WERE STUCK IN THE PATIENT. THE WIRE WAS REMOVED HOWEVER A PORTION OF THE CATHETER REMAINED WITHIN THE PATIENT." A VASCULAR SURGEON WAS CALLED TO FULLY REMOVE THE RETAINED CATHETER. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE". THERE WAS NO OTHER PATIENT HARM OR INJURY. ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00448.

  Patient problems: Foreign Body In Patient

  MAUDE report 19309869 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021120. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1973-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF