ViewMate™ H701336Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067013361), received between Nov 6, 2019 and Dec 3, 2025 — classified as 5 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Sparking; Power Problem; Sparking; Power Problem

  DURING DEVICE PREPARATION WHEN POWERING UP THE VIEWMATE ULTRASOUND DEVICE, A SPARKING SOUND WAS HEARD AND SPARKING WAS VISIBLE. THE DEVICE WOULD NOT POWER ON. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709117 ↗
• InjuryAug 26, 2020Smoking; Smoking

  WHEN THE SYSTEM WAS PLUGGED IN PRIOR TO A PROCEDURE, VISIBLE SMOKE WAS NOTED FROM THE SYSTEM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10455364 ↗
• InjuryAug 21, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE TRANSDUCER COULD NOT BE SELECTED, A BLACK SCREEN WAS NOTED AND THE CASE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT AND THE CASE WAS RESCHEDULED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437235 ↗
• InjuryApr 15, 2020Power Problem; Power Problem

  IT WAS CONFIRMED THE FREEZE ISSUE OCCURRED PRIOR TO THE PATIENT ENTERING THE ROOM AND NO PATIENT WAS INVOLVED. THEREFORE THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9963293 ↗
• InjuryJan 10, 2020Tactile Prompts/Feedback; Tactile Prompts/Feedback

  DURING A PROCEDURE, WHEN THE VIEWMATE SYSTEM WAS STARTED, THE CONSOLE KEYS WERE NOT WORKING AS THE PATIENT INFORMATION COULD NOT BE ENTERED. WHEN THE CATHETER WAS CONNECTED, IT WOULD NOT REGISTER. THE SYSTEM WAS POWER CYCLED, THE PROBES WERE REPLACED, AND THE BATTERY WAS RE-INSERTED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS ULTIMATELY CONTINUED BY SWITCHING TO TEE IMAGING, BUT THIS TRANSITION REQUIRED INCREASED SEDATION TIME FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9577319 ↗
• InjuryNov 6, 2019Output Problem; Output Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00561, 2184149-2019-00209. DURING A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, THE SYSTEM DISPLAYED A "OVERHEATING ERROR" MESSAGE AND THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284089 ↗