VOYANT® Maryland Fusion Device EB216Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00607915139360), received between Sep 30, 2021 and Sep 21, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Insufficient Device Problem Information

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50848575 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50848572 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Patient problems: Hematoma

  MAUDE report 50848557 ↗
• InjuryAug 11, 2026Failure to Seal

  Procedure Performed:Laparoscopic Gastric Sleeve.Event Description:Device failed to seal and caused bleeding. Almost had to switch patient to open surgery. Post-procedure, hemoglobin levels were low, so the patient received a blood transfusion.Information provided on (b)(6) 2026: Remaining sterile units from Lot #1585275 will be returning. Rep will update on quantity.Patient Status:Stable.Intervention:NI.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50215831 ↗
• MalfunctionNov 21, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC GASTRECTOMY. EVENT DESCRIPTION: [HOSPITAL NAME]. EVENT DESCRIPTION:"WHEN DEVICE HOLDING TISSUES, WHEN DOCTORS WANT HOLD TISSUES AND LOCK THE HANDLE, LATCHING MECHANISM HAS PROBLEMS IT DIDN'T LOCK. ALSO, WHEN CLOSED HANDLE IT DIDN'T OPENED. IT BECAME VERY SERIOUS PROBLEMS. BECAUSE OF THIS THEY COULDN'T CONTINUE SURGERY. IT HAPPENED APPROXIMATELY AFTER 80 ACTIVATIONS." ADDITIONAL INFORMATION RECEIVED FROM FIELD TEAM BY EMAIL ON 28 OCTOBER 2025: WAS THE DEVICE CLOSED ON TISSUE? IF SO, WHAT INTERVENTION WAS USED TO REMOVE THE DEVICE? THEY TRIED SO MUCH TO OPEN IT. THEY OPENED. WAS THERE DAMAGE TO THE TISSUE WHEN THE HANDLE DID NOT OPEN? YES, IT DAMAGED TO TISSUE, ALSO TENSION HAPPENED AND BLEEDING HAPPENED BLEEDINGS ON TISSUES ARE SMALL, DOCTOR CONTROLLED IT. CLOSING LETTER NEEDED. INTERVENTION: THEY OPENED [COMPETITOR DEVICE]. PATIENT STATUS: GOOD.

  Patient problems: Laceration(s); Physical Entrapment

  MAUDE report 23624224 ↗
• InjuryFeb 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION: SLEEVE GASTRECTOMY WAS BEING PERFORMED. USAGE WAS WITHIN IFU. NO GENERATOR ERROR CODES WERE RECORDED. SURGEON SUSPECTS 2 THINGS THAT MAY HAVE CAUSED THE EVENT: 1- THE SHORT GASTRIC ARTERIES WERE AFFECTED BY JAW STICKINESS - MAY HAVE "PULLED OFF " COAGULATE WHEN RELEASING JAW. 2- TOO MUCH TISSUE TENSION WHEN DOING THE DISSECTION. PATIENT EXPERIENCED PARISPLENIC HEMATOMA AND WAS READMITTED. NO RE-ENTRY WAS REQUIRED. THE USER RESOLVED THE SITUATION BY CONSERVATIVE TREATMENT FOR POTENTIAL INFECTION AND HEMATOMA. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM [NAME], APPLIED MEDICAL TERRITORY MANAGER, ON (B)(6) 2023: [SURGEON] DOESN¿T RECALL THE SPECIFICS OF THE CASE NOW AS IT'S BEEN A FEW WEEKS SINCE. INTERVENTION: CONSERVATIVE TREATMENT FOR POTENTIAL INFECTION AND HEMATOMA. PATIENT STATUS: SURGEON REPORTED PERISPLENIC HEMATOMA POST-OP. WAS TREATED CONSERVATIVELY AND NO RE-ENTRY WAS REQUIRED. CURRENTLY REPORTED AS RECOVERING.

  Patient problems: Hematoma

  MAUDE report 16391943 ↗
• MalfunctionOct 3, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE. EVENT DESCRIPTION: SURGEON REPORTS THAT FUSE ACTIVATION BUTTON WOULD CAUSE DELAYED AND PROLONGED RESPONSE DURING USE. ENERGY DELIVERY OCCURRED A FEW SECONDS AFTER PRESSING THE FUSE ACTIVATION BUTTON IN PROCEDURE. UPON RELEASING FUSE ACTIVATION BUTTON AND REMOVING DEVICE FROM TISSUE, ENERGY WAS STILL BEING DELIVERED TO THE DEVICE UNTIL AN ERROR CODE INTERRUPTED THE SEAL CYCLE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT INJURY OCCURRED. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530562 ↗
• MalfunctionJun 21, 2022Self-Activation or Keying; Self-Activation or Keying

  PROCEDURE PERFORMED: GASTRIC SLEEVE. EVENT DESCRIPTION: DR [NAME] WAS DOING A GASTRIC SLEEVE PROCEDURE. THE EB216 TOWARDS THE END OF THE CASE WOULD NOT ACTIVATE A SECOND TIME WHEN HE WAS TRYING TO DOUBLE SEAL. I ADVISED DR [NAME] THAT WE DO NOT RECOMMEND DOUBLE SEALING. HE SAID HE UNDERSTANDS AND WANTED TO ANYWAY. HE HAD THE JIGGLE THE ACTIVATION BUTTON A LITTLE TO GET THE SECOND ACTIVATION EACH TIME. SECONDLY WHEN HE WAS FINISHED WITH EB216, HE PLACED IT ON THE MAYO STAND AND THE DEVICE ACTIVATED ON ITS OWN WITH THE JAWS OPEN AND NOBODY TOUCHING IT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 02JUN2022. FROM [NAME], ACCOUNT MANAGER: PATIENT IS FINE AND SHOULD HAVE BEEN RELEASED FROM HOSPITAL TODAY. CASE WAS COMPLETED WITH THE SAME DEVICE. DEVICE WAS USED TO ALMOST THE END OF CASE BEFORE MALFUNCTION OCCURRED (APPROX. 30 ACTIVATIONS). THE ONLY ALARMS IN THE CASE WERE AN OCCASIONAL EARLY RELEASE ALARM. NO ALARMS OCCURRED WHEN THE DEVICE FAILED TO ACTIVATE. JAWS WERE CLEANED TWICE WITH A MOIST 4X4. INTERVENTION: CASE WAS COMPLETED WITH THE SAME DEVICE. PATIENT STATUS: PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756693 ↗
• MalfunctionMay 9, 2022Failure to Conduct; Failure to Conduct

  PROCEDURE PERFORMED: LAP SLEEVE GASTRECTOMY. EVENT DESCRIPTION: THE DEVICE WAS BEING USED TO MOBILIZE THE STOMACH FROM THE OMENTUM. THE DEVICE WAS BEING USED TO SEAL AND TRANSECT TISSUE. FOLLOWING COMPLETION OF THE SEAL CYCLE AND TRANSECTION OF TISSUE, WHEN THE JAW WAS RELEASED FROM THE TISSUE A PERMANENT FUSED SEAL DID NOT OCCUR. BLOOD APPEARED FROM THE SEAL MARGINS. THE BLOOD DID NOT APPEAR IMMEDIATELY IT TOOK APPROXIMATELY 2 SECONDS. THERE WAS NO TENSION ON THE TISSUE DURING THE SEAL CYCLE. THE BLEEDING APPEARED CONSISTENTLY FROM THE FOURTH ACTIVATION ONWARDS. THERE WAS NO ESCHAR ON THE JAWS DURING THE ACTIVATION WHICH CAUSED THE BLEED. THE SEAL CYCLE WAS COMPLETED AND THE END TONE HEARD PRIOR TO TRANSECTION OF THE TISSUE. PRIOR TO CASE IT WAS CONFIRMED THAT PATIENT HAD NO PRE-EXISTING MEDICAL CONDITIONS OR WAS ON ANY MEDICATION THAT WOULD IMPACT THE SEAL QUALITY. PRIOR TO CASE SURGEON HAD SUCCESSFULLY COMPLETED OVER 10 CASES USING VOYANT. LATER IN THE CASE THE BLACK ROTATION KNOB ALSO FELL OFF. THERE WERE NO CHANGES IN HEALTH RESULTING FROM THE EVENT. THE SURGERY CONTINUED USING THE VOYANT DEVICE, WITH MULTIPLE SEAL CYCLES REQUIRED TO CONTROL BLEED. ONCE BLEED WAS CONTROLLED TH

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 14342532 ↗
• MalfunctionOct 13, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NO INFORMATION. DETAILED DESCRIPTION OF EVENT: THE REP WAS NOT PRESENT DURING THE CASE. THE DEVICE PACKAGING WAS OPENED AND WITHIN THE PACKAGE THE SURGICAL TEAM FOUND A HAIR WRAPPED UP IN THE PRONGS OF THE DEVICE KEY. THE DEVICE WAS NOT USED IN THE CASE AND ANOTHER VOYANT WAS OPENED AND USED IN THE CASE. NO PATIENT IMPACT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23SEP2021 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER III: PHOTOS OF THE PRODUCT AND THE HAIR HAS BEEN PROVIDED. PATIENT STATUS: NO PATIENT IMPACT. TYPE OF INTERVENTION: USED NEW DEVICE TO COMPLETE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624244 ↗
• InjurySep 30, 2021Failure to Conduct; Failure to Conduct

  PROCEDURE PERFORMED: EVENT DESCRIPTION: I RECEIVED A TEXT FROM DR [NAME] ON (B)(6) 2021. THE TEXT READ: "I'M NOT USING ANYMORE CDHB VOYANT UNTIL ENTIRE STOCK REPLACED AS CURRENTLY DEFECTIVE. I HAD A MASSIVE LIFE THREATENING BLEED DUE TO ANOTHER CDHB FAILURE OF VOYANT". PATIENT WITH GASTROPARESIS BMI OF 70 GANGRENOUS PORTIONS OF COLON TO BE REMOVED. VOYANT WORKED FINE BUT NEAR THE END OF THE PROCEDURE FAILED ON 2 VESSELS. 2 LARGE BLEEDS OCCURRED AND HAD TO BE CONTAINED. DR [NAME] COMPLETED THE SURGERY USING [DEVICE]. DEVICE FAILED ON SHORT GASTRIC 4MM VESSEL. WAS CLEANED REGULARLY AND SHOWED NO ESCHAR BUILDUP AT THE TIME OF IT FAILING. NO ALARMS REPORTED. ADEQUATE PRESSURE WAS APPLIED TO VESSEL AS SURGEON HAS USED MANY TIMES BEFORE. THIS IS THE 3RD DEVICE THAT HAS FAILED FOR THIS SURGEON. PATIENT HAS RECOVERED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] 01/OCT/2021: VOLUME OF BLOOD WAS NOT MEASURED BUT WAS ENOUGH TO WARRANT THE SITUATION AS LIFE THREATENING. ALL PREVIOUS FAILURES OF THE DEVICE WERE REPORTED IN CER'S. NO ASSOCIATED INJURY OCCURRED AS HEMOSTASIS WAS ACHIEVED USING [DEVICE]. PATIENT HAS SINCE RECOVERED FULLY. INTERVENTION: DR [NAME] COMPLETED THE SURGERY USI

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 12558641 ↗