Ultra ICE Plus M00499120Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729904380), received between Mar 22, 2018 and Jun 18, 2024 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), AN ULTRA ICE PLUS CATHETER WAS SELECTED FOR USE. THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE CATHETER INTO THE SHEATH. SHEATH PACKAGING WAS CHECKED TO CONFIRM IT WAS THE CORRECT SIZE AND IT WAS. THE TIP OF THE ICE CATHETER CRUSHED IN ON ITSELF AS INSERTION WAS ATTEMPTED. IT WAS DECIDED TO REPLACE THE CATHETER AND THE ISSUE WAS RESOLVED. DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559608 ↗
• MalfunctionNov 15, 2023

  ICE MACHINE WAS REGISTERING THE WRONG ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER. THE ULTRA ICE WAS INSERTED, BUT IT WAS READING OPTICROSS 35 INSTEAD. MACHINE REBOOTED AND STILL DID NOT RECOGNIZE CORRECT CATHETER. NEW ICE CATHETER CONNECTED AND WAS IDENTIFIED CORRECTLY BY MACHINE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138912 ↗
• MalfunctionJun 22, 2023Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT IS REPORTABLE DUE TO PI RESULTS. IT WAS REPORTED THAT AN ULTRA ICE PLUS CATHETER WAS SELECTED FOR USE. THERE WAS NO IMAGE DISPLAYED DESPITE CHECKING IT USING A SALINE SOLUTION. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. UPON DEVICE ANALYSIS, KINKS WERE OBSERVED IN THE IMAGING WINDOW ASSEMBLY AND A LEAK WAS OBSERVED IN THE IMAGING WINDOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185420 ↗
• MalfunctionMar 29, 2023Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE CATHETER EXHIBITED POOR SIGNAL QUALITY. DURING A PROCEDURE AN ULTRA ICE PLUS. IT WAS NOTED THE CATHETER EXHIBITED POOR SIGNAL QUALITY. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639683 ↗
• MalfunctionMar 28, 2023Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION OF A MYOCARDIAL ABLATION PROCEDURE TO TREAT AN ATRIAL TACHYCARDIA, AN ULTRA ICE PLUS CATHETER WAS SELECTED FOR USE. THERE WAS A LEAK WHEN INJECTING WATER INTO THE TIP, AND WHEN THE TIP WAS CHECKED, IT WAS DAMAGED. THERE WAS A CRACK AT THE TIP, AND WATER SEEMED TO BE LEAKING FROM THAT PART. CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. CATHETER WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629697 ↗
• MalfunctionDec 23, 2021Poor Quality Image; Poor Quality Image

  DURING AN ABLATION TO TREAT LEFT ATRIAL FLUTTER A ULTRA ICE PLUS CATHETER AND RHYTHMIA MAPPING SYSTEM WERE SELECTED FOR USE. IT WAS REPORTED THAT POOR ULTRASOUND IMAGING/NOISE WAS OBSERVED DURING THE PROCEDURE. THE CATHETER WAS REPLACED, HOWEVER, THE TRANSEPTAL PUNCTURE WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED. FURTHER TROUBLESHOOTING INDICATED THAT THE CAUSE OF THE NOISE WAS THE RHYTHMIA SIGNAL STATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078452 ↗
• MalfunctionJul 15, 2021Unsealed Device Packaging; Material Puncture/Hole; Unsealed Device Packaging; Material Puncture/Hole

  IT WAS REPORTED THAT A ULTRA ICE PLUS WAS SELECTED TO BE USED IN A PROCEDURE. HOWEVER UPON OPENING THE BOX THE STERILE PACKAGING WAS IN AN OPENED STATE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176242 ↗
• MalfunctionSep 1, 2020Material Perforation; Material Perforation

  IT WAS REPORTED THAT A ULTRA ICE PLUS WAS SELECTED FOR USED IN A ATRIAL FIBRILLATION ABLATION PROCEDURE. AFTER THE CATHETER WAS INSERTED INTO THE PATIENT IT WAS NOTED TO BE NOT WORKING PROPERLY. THE CATHETER WAS REMOVED FROM THE PATIENT AND WAS NOTED TO HAVE A CRACK IN THE CATHETER LINING. THE PROCEDURE WAS COMPLETED USING ANOTHER ULTRA ICE PLUS CATHETER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479574 ↗
• MalfunctionMay 28, 2020Crack

  INCIDENT DESCRIPTION: CATHETER WAS INSERTED INTO PATIENT, WAS NOT WORKING PROPERLY. REMOVED AND A CRACK IN CATHETER LINING WAS NOTED. SUBSEQUENTLY, ANOTHER BOSTON SCIENTIFIC 8.5F 110CM CATH ULTRA ICE PLUS ECHO WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10095874 ↗
• MalfunctionMay 6, 2020Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED AS THE ULTRA ICE PLUS WAS INSERTED INTO THE PATIENT, AIR HAD BEEN INTRODUCED INTO THE SYSTEM AND COULD NOT BE REMOVED. THE CATHETER WAS REPLACED WITH ANOTHER ULTRA ICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028809 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERRUPT AF CLINICAL STUDY. FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO ULTRA ICE PLUS CATHETERS, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER AND A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THE PATIENT WAS HOSPITALIZED DUE TO A COMPLAINT OF CHEST PAIN. THE PATIENT WAS GIVEN INTRAVENOUS (IV) FUROSEMIDE 40MG, METHYLPREDNISOLONE (SOLU-MEDROL) 125MG AND LORAZEPAM (ATIVAN) 0.5MG AND THE EVENT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Chest Pain

  MAUDE report 9957116 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERRUPT AF CLINICAL STUDY. FOLLOWING AN ABLATION PROCEDURE WITH AN INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER, TWO ULTRA ICE PLUS CATHETERS, AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER AND A POLARIS X STEERABLE DIAGNOSTIC CATHETER, THE PATIENT WAS HOSPITALIZED DUE TO A COMPLAINT OF CHEST PAIN. THE PATIENT WAS GIVEN INTRAVENOUS (IV) FUROSEMIDE 40MG, METHYLPREDNISOLONE (SOLU-MEDROL) 125MG AND LORAZEPAM (ATIVAN) 0.5MG AND THE EVENT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Chest Pain

  MAUDE report 9957114 ↗
• MalfunctionMay 14, 2019Obstruction of Flow; Device Contamination with Chemical or Other Material; Improper Flow or Infusion; Obstruction of Flow; Device Contamination with Chemical or Other Material; Improper Flow or Infusion

  IT WAS REPORTED THAT FOREIGN MATERIAL PRESENT IN THE TIP OF THE DEVICE. DURING PREPARATION OF THE ULTRA ICE PLUS CATHETER FOR INSERTION INTO THE PATIENT, IT WAS NOT POSSIBLE TO FLUSH THE CATHETER. A FOREIGN OBJECT WAS DISCOVERED IN THE DISTAL TIP. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS PERFORMED WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608202 ↗
• MalfunctionMar 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE A FOREIGN SUBSTANCE WAS NOTED. AN ULTRA ICE PLUS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE WATER INJECTED TO THE TIP OF THE CATHETER LOOKED CLOUDY. FURTHERMORE, THE DEVICE WAS INSERTED TO THE PATIENT'S BODY BUT PHYSICIAN DISCONTINUED THE USAGE AND REMOVED THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362456 ↗