ARROW IPN000099Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902004567), received between Feb 12, 2019 and Nov 18, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “No Device Output” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN SWG (0.025INCH) DID NOT GO THROUGH THE CATHETER. AS A RESULT, THE USER OPENED A NEW KIT, AND THE SWG SUCCESSFULLY WENT THROUGH THE NEW CATHETER AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860948 ↗
• MalfunctionMar 21, 2020No Device Output; Connection Problem; No Device Output; Connection Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER THE CONNECTORS ON THE DEVICES WERE NOT WORKING. AS A RESULT, DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863503 ↗
• MalfunctionMar 16, 2020No Device Output; Connection Problem; No Device Output; Connection Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER THE CONNECTORS ON THE DEVICES WERE NOT WORKING. AS A RESULT, DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836972 ↗
• MalfunctionMar 16, 2020No Device Output; Connection Problem; No Device Output; Connection Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER THE CONNECTORS ON THE DEVICES WERE NOT WORKING. AS A RESULT, DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836884 ↗
• MalfunctionMar 16, 2020No Device Output; Connection Problem; No Device Output; Connection Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER THE CONNECTORS ON THE DEVICES WERE NOT WORKING. AS A RESULT, DEVICE WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836821 ↗
• MalfunctionFeb 12, 2019No Device Output; No Device Output

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE CATHETER, IT WAS NOTED BY THE USER THAT THEY WERE UNABLE TO MEASURE THE PULMONARY ARTERY PRESSURE. AS A RESULT, THE CATHETER WAS REMOVED, AND ANOTHER ATTEMPT WAS MADE WITH A NEW CATHETER SUCCESSFULLY. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330925 ↗