ARROW IPN039999Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902148091), received between Jun 10, 2022 and Jun 27, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER OPENING THE CHEST FOR SURGERY, THE SINGLE LUMEN INFUSION CATHETER WAS NOTED TO BE THROUGH THE INFERIOR ASPECT OF THE INNOMINATE VEIN. THE LINE WAS REMOVED AND THE VEIN WAS REPAIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. CUSTOMER REPORTS ISSUE MAY HAVE BEEN RELATED TO USER ERROR.

  Patient problems: Perforation of Vessels

  MAUDE report 14836276 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICE HAD PERFORATED THE JUNCTION OF THE SUPERIOR VENA CAVA AND THE INNOMINATE VEIN. THIS WAS REPAIRED DURING THE SURGERY AND THE LINE WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. CUSTOMER REPORTED THE ISSUE MAY HAVE BEEN RELATED TO USER ERROR.

  Patient problems: Great Vessel Perforation

  MAUDE report 14836240 ↗
• InjuryJun 10, 2022Use of Device Problem

  THROUGH SEVERAL REVIEW, AN IDENTIFIED TREND WITH SINGLE LUMEN INFUSION CATHETER AND INTRAOPERATIVE COMPLICATION - DEVICE HAD PERFORATED JUNCTION OF THE SUPERIOR VENA CAVA AND THE INNOMINATE VEIN. THIS WAS REPAIRED DURING THE SURGERY AND LINE WAS REMOVED. DETERMINED THAT THIS DEVICE TYPE IS NO LONGER USED BY ANESTHESIA GROUP. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 14676472 ↗
• InjuryJun 10, 2022Use of Device Problem

  AFTER SEVERAL REVIEWS, IT WAS NOTED THAT THERE WAS AN INJURY DURING SURGERY THAT WAS A TREND. AFTER OPENING THE CHEST FOR SURGERY, THE SINGLE LUMEN INFUSION CATHETER WAS NOTED TO BE THROUGH THE INFERIOR ASPECT OF THE INNOMINATE VEIN. THE LINE WAS REMOVED, AND THE VEIN WAS REPAIRED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 14676367 ↗