POLARMAP™ M004CRBS7210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506039769), received between Dec 26, 2023 and Jul 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER SHAFT WAS DAMAGED OR DEFECTIVE. DURING PREPARATION PRIOR TO A PROCEDURE FOR TREATING ATRIAL FIBRILLATION (AFIB), A POLARMAP CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE CATHETER BECAME STUCK IN THE TUOHY VALVE AND COULD NOT BE RETRACTED. UPON RELEASE, SLIGHT DAMAGE OR SHEARING OF THE CATHETER SHAFT NEAR THE ELECTRODES WAS NOTED. AN ATTEMPT WAS MADE TO LOOSEN THE TUOHY VALVE TO FREE THE CATHETER WITHOUT CAUSING FURTHER DAMAGE, BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WAS DISPOSED OF BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645789 ↗
• MalfunctionDec 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING THE PREPARATION OF A CRYOABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AF), A POLARMAP CATHETER WAS SELECTED FOR USE. DEVICE BECAME UNSTERILE AND IT WAS DECIDED TO REPLACE IT RATHER THAN PROCEED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS LOOPED ON THE PATIENT FIELD. IT BECAME UNSTERILE WHEN UNWRAPPED AND IT HIT THE SCRUB NURSE IN THE HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393473 ↗