NA IBI-85786Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734309080), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P060019); 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.

• MalfunctionMar 6, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PVC PROCEDURE, IT WAS NOTED THAT THE COOL POINT PUMP STOPPED WHEN ABLATION WAS DISCHARGED WHICH RESULTED IN PROCEDURAL DELAYS. THE PUMP WAS RESTARTED, THE RADIO FREQUENCY INSTRUMENT WAS RESTARTED, AND THE PUMP WAS CHANGED BUT THE ISSUE WAS NOT RESOLVED. THE PUMP CABLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484900 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060019. One submission often covers many models, so check the product and lot details in each record.

• Z-1032-2012 · Jan 5, 2012 · Terminated
  The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Abl