EnSite Precision™ EN0020-P (UDI 05415067025937)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05415067025937), received between Aug 23, 2019 and Apr 23, 2021 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING PREPARATION, THE CORD TO THE REFERENCE PATCH WAS CRUSHED AND APPEARED TO BE BURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715369 ↗
• MalfunctionApr 1, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURING REF: 3008452825-2021-00213. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, ABNORMAL MOVEMENT OCCURRED ON THE CATHETERS OCCURRED DURING ABLATION. NEW ABLATION CATHETERS AND NEW PATCH KITS WERE OPENED TO MITIGATE THE ISSUE. HOWEVER, THE ELECTRODE ON ONE OF THE PATCHES THAT IS SUPPOSED TO BE COVERED IN GEL IS EXPOSED. THE CASE WAS ABORTED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602749 ↗
• InjuryOct 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  FOLLOWING AN ATRIAL ARRHYTHMIA PROCEDURE, THE ENSITE PATCHES WERE REMOVED FROM THE PATIENT AND IT WAS NOTED THE NECK AND BACK PATCHES WERE INCORRECTLY SWAPPED THROUGHOUT THE PROCEDURE. THE PATIENT ARRIVED TO THE PROCEDURE ROOM WITH AN ARRHYTHMIA FOR A REDO ABLATION PROCEDURE. THE LOCATION OF THE ARRHYTHMIA WAS FOUND TO BE ORIGINATING FROM THE RIGHT ATRIUM BUT BELOW THE SEPTUM. THE GEOMETRY APPEARED SOMEWHAT DISTORTED HOWEVER, THE MAPPING PORTION OF THE PROCEDURE WAS COMPLETED WITH THIS INCORRECT PLACEMENT. THE PROCEDURE WAS UNSUCCESSFUL AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. IT IS UNKNOWN IF THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619315 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, A SKIN TEAR OCCURRED. WHILE BEING REMOVED, THE SURFACE ELECTRODE PATCH TORE THE SKIN ON THE LEFT UPPER THIGH. THE SITE OF THE PATCH WAS BLEEDING. THE SKIN WAS PREPPED PER THE IFU GUIDELINES. BANDAGE DRESSING WAS ADMINISTERED TO THE PATIENT FOR TREATMENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Skin Tears

  MAUDE report 10408416 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATRIAL FIBRILLATION ABLATION, THE PATIENTS SKIN WAS TORN WHEN REMOVING THE BLUE PATCH FROM THE PATIENTS LEG. THE DAMAGE WAS LOCALIZED ON THE LEFT KNEE.

  Patient problems: Skin Tears

  MAUDE report 9483157 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATCH WAS PLACED ON THE LOW BACK. THE GROUNDING PAD DID NOT OVERLAP ANY OTHER PATCHES. IT IS UNKNOWN IF THERE WERE ANY WRINKLES OR EDGES THAT WERE LIFTED ON THE PATCH. THE BURN WAS CATEGORIZED AS THIRD DEGREE. BANDAGES WERE ADMINISTERED TO TREAT THE BURN. CURRENTLY, THE BURN IS HEALED HOWEVER IT WILL SCAR. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Burn(s)

  MAUDE report 9328200 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A PROCEDURE A SKIN TEAR OCCURRED WHEN THE PATCH WAS REMOVED.

  Patient problems: Skin Tears

  MAUDE report 8926520 ↗