Ampere™ H700494Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067004949), received between Dec 7, 2018 and Jun 1, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023High impedance; High impedance

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, HIGH IMPEDANCE WAS NOTED WHICH CAUSED A DELAY. HIGH IMPEDANCE WAS NOTED ON THE CATHETER BEFORE RF. WHEN ABLATION STARTED, A HIGH IMPEDANCE ERROR OCCURRED. THE ABLATION CATHETER AND GROUNDING PADS WERE EXCHANGED WHICH DID NOT RESOLVED THE ISSUE. ADDITIONALLY, THE TACTISYS TO AMPERE RF CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE AMPERE GENERATOR WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039747 ↗
• MalfunctionMay 9, 2023High impedance; High impedance

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, IMPEDANCE ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THERE WAS HIGH IMPEDANCE (ABOVE 150 OHMS) DURING ABLATION. THE RF CABLES AND CATHETER WERE EXCHANGED, BUT THE ISSUE PERSISTED AND THE PROCEDURE WAS CANCELLED. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900083 ↗
• MalfunctionJul 22, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE WITH THE PATIENT ON THE TABLE, THE GENERATOR DID NOT RECOGNIZE THE CATHETER AND THE CASE WAS CANCELLED. THERE WERE NO SIGNALS GETTING TO CLARIS OR THE ENSITE SYSTEM. TROUBLESHOOTING INCLUDED, NEW CONNECTING CABLES, CATHETERS, POWER CYCLING, A NEW AMP TO AMPERE CABLE WITH NO RESOLVE. THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084513 ↗
• InjuryDec 20, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING ABLATION, THE ABLATION CATHETER IN USE WAS OBSERVED ON THE ENSITE SYSTEM TO JUMP AROUND. WHEN ABLATION WAS STOPPED, THE ABLATION CATHETER SLOWLY RECOVERED. TWO ABLATION CATHETERS WERE TRIED AND THE ISSUE OCCURRED ON BOTH CATHETERS. THE ISSUE ONLY OCCURRED WHEN ON RF, SO THE POSITION WAS CONFIRMED ON ENSITE BEFORE COMING ON AND THEN FLUORO WAS WATCHED TO CONFIRM CATHETER STABILITY DURING ABLATION.THE CASE WAS COMPLETED USING FLUOROSCOPY. THE PATIENT WAS UNDER CONSCIOUS SEDATION DURING THE PROCEDURE AND IS NOW ENTIRELY PACER-DEPENDENT, WHICH WAS THE EXPECTED OUTCOME OF THE AV NODE ABLATION. A REPLACEMENT EGM CABLE WAS SENT TO RESOLVE THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507383 ↗
• InjuryDec 7, 2018Unintended Electrical Shock; Unintended Electrical Shock

  DURING THE PROCEDURE, THE ABBOTT PERSONNEL RECEIVED AN ELECTRICAL SHOCK WHEN REMOVING A RETURN LABEL FROM THE AMPERE GENERATOR. THE OPERATOR'S FINGER WENT NUMB FOR A PERIOD OF TIME BUT THERE WAS NO HARM TO THE PATIENT OR USER.

  Patient problems: Electric Shock

  MAUDE report 8143412 ↗