Polaris X™ M0047003D0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729270164), received between Aug 3, 2018 and Aug 8, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE CATHETER. UPON REMOVAL, IT WAS NOTED THAT THE CATHETER WAS ENTANGLED AND SEVERELY KINKED. DURING AN ABLATION PROCEDURE, A POLARIS X WAS USED TO TREAT SUPRAVENTRICULAR TACHYCARDIA (SVT). WHEN REMOVING THE CATHETER, IT WAS NOTED THAT THE CATHETER WAS DIFFICULT TO REMOVE AS IT BECAME ENTANGLED. UPON REMOVAL, IT WAS OBSERVED THAT THE CATHETER WAS SEVERELY KINKED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754920 ↗
• MalfunctionAug 13, 2024Material Integrity Problem; Material Integrity Problem

  DURING PROCEDURE, THE POLARIS X WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TIP END PEELS OFF AND THE WIRE PROTRUDES. THE DEVICE HAS BEEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE PRODUCT WAS RETURNED FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973425 ↗
• MalfunctionOct 19, 2023Defective Device; Defective Device

  DURING AN ELECTROPHYSIOLOGY ABLATION A POLARIS X WAS SELECTED FOR USE. THE PATIENT HAD A DIFFERENT CARDIAC ANATOMY, SO ACCESS TO THE CORONARY SINUS WAS MORE DIFFICULT THAN USUAL. THIS MADE IT MORE DIFFICULT FOR THE DOCTOR TO ACCESS IT. IN ORDER TO DO THIS, THE PHYSICIAN HAD TO FORCE THE CATHETER A LITTLE MORE THAN USUAL AND THIS ENDED UP DAMAGING THE POLARIS X CATHETER, EVEN FRACTURING SOME OF THE ELECTRODES. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967986 ↗
• MalfunctionOct 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A WIRE ON THE CATHETER WAS EXPOSED. DURING AN ABLATION PROCEDURE FOR RIGHT ATRIAL FLUTTER, THE PHYSICIAN OBSERVED THAT THERE WAS AN EXPOSED WIRE BEHIND THE SECOND ELECTRODE OF THE POLARIS X CATHETER. IT APPEARED THAT THE COVERING HAD DISCONNECTED. THE CATHETER HAD BEEN IN THE PATIENT'S RIGHT ATRIUM. IT WAS EXCHANGED FOR ANOTHER CATHETER OF THE SAME MODEL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141676 ↗
• MalfunctionAug 6, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. DURING A PROCEDURE WITH A POLARIS X, THE CATHETER WAS BROKEN WHEN OPENED. A NEW CATHETER WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8866372 ↗
• MalfunctionMay 7, 2019Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A POLARIS X WAS SELECTED FOR AN ABLATION PROCEDURE; HOWEVER, IT WAS NOTED THAT THE CATHETER SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586466 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-60917, 2134265-2018-60919, 2134265-2018-60918. IT WAS REPORTED THAT HYPOTENSION, THIRD DEGREE HEART BLOCK AND PERFORATION OCCURRED. DURING AN ABLATION PROCEDURE FOR LEFT ATRIAL FLUTTER, A POLARIS X, AN INTELLAMAP ORION, AN INTELLANAV MIFI OI LRG CURVE AND INTELLANAV MIFI OI STD CURVE WERE SELECTED FOR USE. THE PHYSICIAN MAPPED THE LEFT ATRIUM USING THE ORION MAPPING CATHETER WHILE PACING FROM THE CORONARY SINUS (CS) CATHETER. HE REMOVED THE ORION FROM THE LEFT ATRIUM AND REPLACED IT WITH AN INTELLANAV MIFI OI LRG CURVE CATHETER. AFTER COMING ON ABLATION FOR 3 SECONDS, THE GENERATOR GAVE A D07 EXCESSIVE TEMPERATURE ERROR. HE CHANGED ABLATION CABLES AND INSPECTED THE CATHETER TIP FOR EVIDENCE OF CHAR AND DID NOT SEE ANY. THE REAL TIME TEMPERATURE READING ON THE ABLATION GENERATOR WAS GIVING AN INTERNAL TEMPERATURE OF 86 DEGREES. THE PHYSICIAN DID NOT REINSERT THE CATHETER INTO THE BODY AND REPLACED IT WITH AN INTELLANAV MIFI OI STD CURVE ABLATION CATHETER AND BEGAN TO ABLATE. THEY WERE ABLE TO DELIVER RADIOFREQUENCY (RF) WITHOUT ANY ERRORS AND ABLATED. THEY DID NOT NOTICE ANY ABNORMAL READINGS IN REGARD TO TEMPERATURE, POWER AND IMPEDANCE. THEY ABLAT

  Patient problems: Cardiac Perforation; Complete Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 7885062 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE IN WHICH A POLARIS X DIAGNOSTIC CATHETER HAD BEEN USED, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE EFFUSION OCCURRED FOLLOWING DUAL TRANS-SEPTAL ACCESS AND INTRA-ABLATION OF THE PULMONARY VEINS. A PERICARDIOCENTESIS WAS PERFORMED AND THE PHYSICIAN PROCEEDED WITH ABLATION OF THE PULMONARY VEINS. THERE WAS NO CERTAINTY ABOUT WHAT CAUSED THE EFFUSION. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pericardial Effusion

  MAUDE report 7746496 ↗