VOYANT® 5mm Fusion Device EB211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915138431), received between Jul 18, 2023 and Aug 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: BARIATRIC SURGERY. EVENT DESCRIPTION: AFTER THE LAST FUSION THE ACTIVATION BUTTON CONTINUED TO LAUNCH FUSION CYCLE AFTER USING THE DEVICE SEEING SEVERAL TIMES THE FUSION ACTIVATION BUTTON REMAINED BLOCKED. PATIENT STATUS: NO PROBLEM. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22746415 ↗
• MalfunctionJul 18, 2023Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: BYPASS EVENT DESCRIPTION: TRANSLATION: ONCE CONNECTED, MESSAGES APPEARED REPEATEDLY. IMPOSSIBLE TO USE THE DM. AFTER PLUGGING IN THE DEVICE, MESSAGES APPEARED FROM THE FIRST USE (CLEAN DEVICE). IMPOSSIBILITY OF USE ...REPEATED MESSAGES. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 01DEC22: TRANSLATION: THERE WERE NO CONSEQUENCES, INJURY OR OTHERWISE, FOR THE PATIENT BUT A BAD COAGULATION THAT GENERATED SEVERAL CATCHES AND INCREASED THE STRESS OF THE SURGERY. NO CONSEQUENCES TO REPORT FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 6DEC23: THIS STATEMENT MEANS NO CONSEQUENCE FOR THE PATIENT AND THE SURGERY TOOK LONGER THAN EXPECTED DUE TO THIS PROBLEM WITH THE VOYANT DEVICE. THE DEVICE ACTIVATED BUT THE COAGULATION WAS BAD AND SEVERAL MESSAGES APPEARED REPEATEDLY ON THE GENERATOR SUCH AS ¿CLEAN THE DEVICE. ¿ TYPE OF INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: THERE WERE NO CONSEQUENCES, INJURY OR OTHERWISE. THE SURGERY TOOK LONGER THAN EXPECTED DUE TO THIS PROBLEM WITH THE VOYANT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344422 ↗