Cool Point™ H701666Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067016669), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PRESSURE ERROR THAT WOULD NOT RESOLVE RESULTING IN CANCELLATION OF THE PROCEDURE. THE PRESSURE ERROR WOULD INTERMITTENTLY RESOLVE ITSELF BY MANIPULATING THE PRESSURE ADAPTER CABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE CABLE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128853 ↗

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