ARROW IPN033140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902100559), received between Jul 10, 2023 and Jul 15, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K810962); 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.

• MalfunctionJul 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT "THE PLACEMENT OF A CATHETER IN THE DISSECTION ARTERY IS REPORTED. WHEN CHECKING PERMEABILITY, A FRACTURE IS OBSERVED IN THE LUMEN ON THE EXTERNAL PART OF THE INSERTION, SO IT IS INDICATED TO CHANGE THE CATHETER." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22506219 ↗
• MalfunctionAug 4, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING INSERTION OF CVC ON A 20-MONTH-OLD BABY, THE DOCTOR OBSERVED THAT THE SWG DOES NOT ADVANCE IN THE CATHETER. THERE IS IMPORTANT RESISTANCE WITH RISK TO DAMAGE THE SWG." THE GUIDEWIRE WAS CHANGED AND CVC INSERTED SUCCESSFULLY WITHOUT ISSUE. IT WAS REPORTED THERE WAS AN INCREASE OF GENEREAL ANESTHESIA TIME. THE INFANT WAS UNDER ANESTHESIA A TOTAL TIME OF 1 HOUR AND 30 MINUTES. IT WAS REPORTED "THE INFANT WAS DISCHARGED FROM HOSPITAL. NO CLINICAL CONSEQUENCES RELATED TO THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463555 ↗
• MalfunctionJul 10, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "DURING THE PASSAGE OF A PEDIATRIC CENTRAL VENOUS CATHETER, IT IS OBSERVED THAT WHEN THE CATHETER IS ADVANCED THROUGH THE GUIDE WIRE, IT DOES NOT PRESENT A DISTAL ORIFICE. USE OF ANOTHER CATHETER IS REQUIRED." NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295488 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810962. 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-1960-2018 · Apr 11, 2018 · Terminated
  Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418