EnSite Precision™ Link, Sensor Enabled™ H702475Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05415067024756), received between Jun 7, 2019 and Jun 26, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Sparking” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT INTRACARDIAC SIGNALS WERE LOST. AN ATTEMPT TO CONTACT TECHNICAL SUPPORT WAS MADE BUT WITHOUT SUCCESS. THE ECG WAS CONNECTED MORE SECURELY WHICH RESOLVED THE ISSUE, BUT THE PROCEDURE HAD ALREADY BEEN CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT AND IT IS UNKNOWN IF THE PROCEDURE HAS BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615699 ↗
• MalfunctionMar 29, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING DEVICE PREPARATION FOR A PULMONARY VEIN ISOLATION PROCEDURE, IT WAS REPORTED THE PRECISION LINK POWER SUPPLY PORT APPEARED DAMAGED AND CHARRED. WHEN TRYING TO RECONNECT, IT WAS PLUGGED IN BUT DID NOT TURN ON. IT IS NOTED THAT THE POWER CORD ALSO HAD A LOOSE FIT WITHIN THE PORT. THE PROCEDURE WAS COMPLETED WITHOUT USING THE FIELD FRAME AND THE ENSITE PRECISION LINK. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003648 ↗
• MalfunctionFeb 17, 2023Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REFERENCE: 2184149-2023-00040. DURING THE SVT ABLATION PROCEDURE, IT WAS NOTED THAT THERE WAS NO MAGNETIC LOCATION WHICH CAUSED DELAYS TO TREATMENT. A LINK AND FIELD FRAME FROM A SECOND SYSTEM WERE USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400694 ↗
• MalfunctionJul 26, 2022Output Problem; Output Problem

  RELATED MANUFACTURING REF: 2184149-2022-00178, 3008452825-2022-00530. DURING A FOCAL ATRIAL TACHYCARDIA PROCEDURE, A PROCEDURE DELAY OCCURRED. THE TACTICATH SE WOULD NOT REGISTER CONTACT FORCE AND ANOTHER WAS OBTAINED TO RESOLVE THE ISSUE. NEXT, THE TACTISYS WOULD NOT CONNECT AS IT WAS THOUGHT TO HAVE OVERHEATED. THE TACTISYS WAS REPLACED AND THE ISSUE WAS RESOLVED. ADDITIONALLY, THE ENSITE PRECISION LINK PROVIDED ERROR MESSAGES TO ENSITE PRECISION. IT WAS REPLACED WITH A DIFFERENT PRECISION LINK, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102984 ↗
• MalfunctionMar 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION ENSITE PRECISION CASE USING SE FIELD SCALING, A PROLONGED PROCEDURE OCCURRED. THE COLLECTED GEOMETRY CHANGED TO A FLAT, LONG PICTURE AND THE ABLATION CATHETERS OPTICAL PULL TOGETHER. SE POINTS WERE COLLECTED AROUND THE CHAMBER AND THE PRS WAS LOCATED IN A CORRECT POSITION. THE SYSTEM WAS RESTARTED FOUR TIMES AND ALL CABLE CONNECTIONS WERE CONFIRMED, WITHOUT SE FIELD SCALING THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13932448 ↗
• MalfunctionFeb 24, 2022Arcing; Arcing

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING TWO DISCOLORED/BLACKENED PINS WHICH WAS ISOLATED TO AN ELECTRICAL ARC AT THE REAR POWER INLET CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591638 ↗
• MalfunctionOct 25, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PROLONGED PROCEDURE OCCURRED DUE TO EXPERIENCING AN ERROR MESSAGE WITH THE SYSTEM AND THE TROUBLESHOOTING INVOLVED IN ORDER TO RESOLVE THE ISSUE. WHEN ALL THE EQUIPMENT WAS CONNECTED, THE PRECISION LINK DID NOT CONNECT AND THE SYSTEM DISPLAYED AN ERROR MESSAGE. MULTIPLE TROUBLESHOOTING EFFORTS WERE CONDUCTED, AND LASTLY, WHEN THE PRECISION LINK WAS EXCHANGED, THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12691798 ↗
• MalfunctionSep 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS BEING SUBMITTED BASED ON ANALYSIS WHICH REVEALED A THERMAL EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416144 ↗
• MalfunctionJul 12, 2021Smoking; Smoking

  DURING TROUBLESHOOTING OUTSIDE OF A PROCEDURE, WHEN THE FIELD FRAME CABLE WAS CONNECTED TO THE PRECISION LINK AND FIELD FRAME, THE PRECISION LINK STARTED TO SMOKE AND EMIT A BURNING ODOR. THE CABLE WAS IMMEDIATELY DISCONNECTED. THERE WAS NO PATIENT INVOLVED AND THE USER WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149065 ↗
• MalfunctionMar 25, 2021Sparking; Sparking

  PRIOR TO THE PROCEDURE, THERE WAS SPARKING AT THE PRECISION LINK POWER SUPPLY. THE PRECISION LINK POWER SUPPLY WAS DAMAGED AND SPARKED WHEN IT WAS PLUGGED INTO THE PRECISION LINK. THE LOCKING COLLAR ON THE POWER SUPPLY WAS NOTED TO BE MISSING. IT WAS NOT MISSING AT THE PREVIOUS CASE ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570158 ↗
• MalfunctionJan 7, 2021Thermal Decomposition of Device; Device Emits Odor; Thermal Decomposition of Device; Device Emits Odor

  DURING THE PROCEDURE, THE PRECISION LINK SMELLED OF BURNING AND DISPLAYED ARCING WHEN POWERED ON. AN ARCED/BLACKENED SPOT IS VISIBLE ON ONE OF THE SPOTS WHERE THE 4 PIN PRONG IS INSERTED FOR POWER. THE COVER WAS TAKEN OFF THE LINK AND NO INTERNAL DAMAGE WAS NOTED OTHER THAN THE POWER CONNECTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR THE USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11132560 ↗
• MalfunctionFeb 24, 2020Sparking; Sparking

  WHILE CONNECTING THE PRECISION LINK POWER CABLE TO THE POWER OUTLET SPARKS WERE DETECTED. BLACK RESIDUE WAS OBSERVED ON THE POWER SUPPLY. THERE WERE NO PATIENT OR USER ADVERSE CONSEQUENCES DUE TO THE SPARK AND THE PRECISION LINK WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747040 ↗
• MalfunctionDec 30, 2019Sparking; Sparking

  DURING SET UP FOR A PROCEDURE THE ENSITE PRECISION LINK POWER SUPPLY CABLE FELL APART AND SPARKED. A DIFFERENT POWER SUPPLY WAS UTILIZED FOR THE SCHEDULED PROCEDURE. THERE WERE NO USER CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 9531935 ↗
• MalfunctionAug 6, 2019Sparking; Sparking

  DURING HARDWARE SET UP PRIOR TO THE PROCEDURE, A SPARK WAS NOTED WHEN PLUGGING IN THE POWER SUPPLY OF THE PRECISION LINK. TRACES OF POWDER WERE VISIBLE AT THE CONNECTION BETWEEN THE CABLE AND THE CONNECTOR. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866163 ↗
• MalfunctionAug 1, 2019Sparking; Sparking

  RELATED MANUFACTURER REFERENCE: 2184149-2019-00143. DURING PREPARATION, A SPARK WAS NOTED WHEN USING THE PRECISION LINK POWER INPUT. SOME OF THE PINS APPEARED TO HAVE FUSED TOGETHER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851348 ↗
• MalfunctionJun 7, 2019Arcing; Arcing

  DURING SYSTEM SET UP, THE PRECISION LINK APPEARED CHARRED AT THE AC INPUT AND BLACK RESIDUE WAS NOTED. NO SMOKE OR FIRE WAS PREVIOUSLY OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678483 ↗