ARROW IPN919932Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902198300), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K945229); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT, "WE TRIED TO SUE A TEMPORARY PACING CATHETER WITH SHROUDED PINS/INTRODUCER KIT. IT WAS NOT CAPTURING OR SENSING. THE CATHETER WAS DISCARDED AND WE GOT ANOTHER CATHETER AND IT WORKED FINE. WE ARE QUESTIONING IF THIS ONE WAS FAULTY". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS OR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17480649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945229. One submission often covers many models, so check the product and lot details in each record.

• Z-3197-2018 · Jul 30, 2018 · Terminated
  ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in elec