Ampere™ Remote ControlRecalls & reported problems
St. Jude Medical, Inc. · Remote Control · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067004901), received between Aug 30, 2018 and Mar 5, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Communication or Transmission 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.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem1
- High impedance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Communication or Transmission Problem; Communication or Transmission Problem
DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE AMPERE GENERATOR WAS UNABLE TO CONNECT TO THE ENSITE X. ATTEMPTED MULTIPLE REBOOTS, RESEATED CONNECTIONS, REBOOTED THE ENTIRE SYSTEM, AND STARTED A NEW STUDY WITH NO RESOLVE. REPLACED THE AMPERE FIBER, THE AMPERE, THE AMPLIFIER, AND IT WAS STILL NOT POSSIBLE TO CONNECT THE AMPERE TO THE ENSITE X. THE AMPERE REMOTE WAS REMOVED, AND THE AMPERE CONNECTED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18841865 ↗InjuryAug 30, 2018High impedance; High impedance
RELATED MANUFACTURING REFERENCE: 2182269-2018-00107, 9680001-2018-00127, 2184149-2018-00145. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CANCELLATION OCCURRED. WHILE ABLATING IN THE LEFT ATRIUM, APPROXIMATELY 1 HOUR INTO THE PROCEDURE, AN IMPEDANCE OF 999 WAS DISPLAYED ON THE REMOTE CONTROL AND THE GENERATOR. ADDITIONALLY A "POP" WAS FELT BY THE USER FROM EITHER THE CATHETER OR THE SHEATH WITHIN THE PATIENT. THE SHEATH AND THE CATHETER WERE EXAMINED FOR ABNORMALITIES. THE SHEATH WAS NOTED TO BE DIFFICULT TO MANEUVER BUT NO VISIBLE ABNORMALITIES WERE OBSERVED. THE IMPEDANCE FROM THE GENERATOR HOWEVER DID NOT IMPROVE AND THE CASE WAS CANCELLED. THE PATIENT WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7833355 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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