VOYANT Maryland Fusion DeviceRecalls & reported problems across all models

We found 5 models of VOYANT Maryland Fusion Device by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Sep 21, 2026 — classified as 30 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VOYANT Maryland Fusion Device problems

VOYANT Maryland Fusion Device models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VOYANT® Maryland Fusion Device EB215

  Electrosurgical, Cutting & Coagulation & Accessories
  85 reports
• VOYANT® Maryland Fusion Device EB217

  Electrosurgical, Cutting & Coagulation & Accessories
  28 reports
• VOYANT® Maryland Fusion Device EB216

  Electrosurgical, Cutting & Coagulation & Accessories
  11 reports
• VOYANT® Maryland Fusion Device EB015

  Electrosurgical, Cutting & Coagulation & Accessories
  7 reports
• VOYANT® Maryland Fusion Device EB017

  Electrosurgical, Cutting & Coagulation & Accessories
  1 report

Recent VOYANT Maryland Fusion Device adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 8, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672177 ↗
• MalfunctionAug 14, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258911 ↗
• 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 ↗
• MalfunctionJul 28, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063698 ↗
• MalfunctionApr 13, 2026Failure to Deliver Energy; Mechanical Jam

  PROCEDURE PERFORMED: EBENTRACION. EVENT DESCRIPTION: USE IT CORRECTLY. I WAS SEALING A GLASS AND THE CLAMP JAMMED. PATIENT STATUS: OK. INTERVENTION: WAS REPLACED BY ANOTHER EB217.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860999 ↗
• MalfunctionMar 16, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGECTOMY. EVENT DESCRIPTION: THE DOCTOR WAS PERFORMING A LAPAROSCOPIC SALPINGECTOMY. THE DEVICE WAS PLUGGED IN AND THE VOYANT GENERATOR SAID DEVICE READY. IT MADE THE SOUND OF BURNING BUT NO HEAT WAS APPLIED TO THE TISSUE. WHEN THE DR CUT THE TISSUE HE COULD SEE THAT NO THERE WAS NO BURNING OF THE TISSUE AND IT WAS BLEEDING. INFORMATION FROM DISTRIBUTOR FORM: THE DEVICE WAS PLUGGED IN AND THE VOYANT GENERATOR SAID DEVICE READY. IT MADE THE SOUND OF BURNING BUT NO HEAT WAS APPLIED TO THE TISSUE. WHEN THE DR CUT THE TISSUE, HE COULD SEE THAT NO THERE WAS NO BURNING OF THE TISSUE AND IT WAS BLEEDING. ADDITIONAL INFORMATION RECEIVED BY DISTRIBUTOR VIA EMAIL ON 10-MAR-26: THE BLEEDING WAS OBSERVED 1-2 SECONDS, 2 ACTIVATIONS AFTER THE JAWS WERE REMOVED. THE BLEEDING WAS REMOVED USING ANOTHER VOYANT. THE FALLOPIAN TUBES WERE BEING SEALED. THE BLEEDING WAS NOT OBSERVED FROM A SPECIFIC VESSEL SEAL. GENERAL OOZING OBSERVED AROUND A TISSUE BUNDLE. NO VASCULAR PATHOLOGY. TENSION WAS APPLIED, FALLOPIAN TUBES WERE BEING HELD WITH A SOFT GRASPER. NO ESCHAR BUILDUP. THE JAWS WERE NOT CLEANED. NO ALARMS. THE "SOUND OF BURNING" IS THE SHORT PEEP PEEP PEEP SOUND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613148 ↗
• MalfunctionMar 2, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPROSCOPIC SALPINGECTOMY, ADESIOLYSIS, CYSTECTOMY. EVENT DESCRIPTION: DURING A GYNAE LAPAROSCOPIC PROCEDURE, WHEN TRYING TO ACTIVATE THE DEVICE NO ACTION WAS RENDERED. NO BURNING. VOYANT GENERATOR DID NOT SHOW ANY ERROR CODES EITHER. [SURGEON NAME REDACTED] WAS DOING A LAP CASE ON A PATIENT, STAFF OPENED THE DEVICE AND PLUGGED IT INTO THE GENERATOR AS PER USUAL. NO ERROR CODES DISPLAYED. DISPLAY READ READY. BUT WHEN THE SURGEON TRIED ACTIVATING THE DEVICE BY PRESSING THE ACTIVATION BUTTON NOTHING WAS BURNING, NO SMOKE, NO BURN, TRIED A FEW TIMES AND OPENED THE DEVICE AND REAPPLIED TO SMALLER AMOUNT OF TISSUE AND STILL NO BURN. THE STAFF THEN CONTACTED ME AND ADVISED ON THE SITUATION AND I SAID THEY COULD THEN OPEN A NEW DEVICE. THEY TRIED A SECOND DEVICE AND THE SAME THING HAPPENED. BUT THEY CHARGED THE PATIENT FOR THIS ONE. HAD THE SAME LOT NUMBER AS THE FIRST DEVICE. WAS A VERY SICK PATIENT WHO WAS BLEEDING, SO SURGEON REVERTED TO AN OPEN PROCEDURE. I DID ADVISE THE STAFF MEMBER TO PLEASE KEEP ME THE FAULTY DEVICE SO I COULD SEND IT FOR PRODUCT COMPLAINT. I ALSO SPOKE TO THE STOCK CONTROLLER AND ASKED HIM TO PLEASE ADVISE THE STAFF TO KEEP THE DEVICE. BUT WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491516 ↗
• MalfunctionFeb 26, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE EVENT DESCRIPTION: [HOSPITAL NAME] DESCRIPTION RECEIVED FROM THE FIELD TEAM MEMBER ON (B)(6) 2026: "THE SURGEON REPORTED THAT WHILE USING THE DEVICE INTRAOPERATIVELY, IT UNEXPECTEDLY STOPPED SEALING TISSUE/VESSELS EVEN THOUGH HE WAS PRESSING THE ACTIVATION BUTTON AND THERE WAS A SOUND FROM THE GENERATOR; HOWEVER, NO SEALING OR CUTTING EFFECT WAS ACHIEVED." DESCRIPTION REPORTED BY SFDA BY EMAIL ON FEBRUARY 25, 2026: "THE DEVICE IS DESIGNED TO CAUTERIZE AND CUT AT THE SAME TIME; HOWEVER, IT NEITHER CAUTERIZES NOR CUTS." INTERVENTION: USED ANOTHER COMPETITOR DEVICE. PATIENT STATUS: NO INJURY OR ILLNESS.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462431 ↗
• MalfunctionFeb 11, 2026Failure to Seal

  PROCEDURE PERFORMED: LAPRASCOPIC SALPINGECTOMY, ADESIOLYSIS,CYSTECTOMY. EVENT DESCRIPTION: DURING A GYNAE LAPRASCOPIC PROCEDURE, WHEN TRYING TO ACTIVATE THE DEVICE NO ACTION WAS RENDERED. NO BURNING. VOYANT GENERATOR DID NOT SHOW ANY ERROR CODES EITHER. [SURGEON NAME REDACTED] WAS DOING A LAP CASE ON A PATIENT, STAFF OPENED THE DEVICE AND PLUGGED IT INTO THE GENERATOR AS PER USUAL. NO ERROR CODES DISPLAYED. DISPLAY READ READY. BUT WHEN THE SURGEON TRIED ACTIVATING THE DEVICE BY PRESSING THE ACTIVATION BUTTON NOTHING WAS BURNING, NO SMOKE, NO BURN, TRIED A FEW TIMES AND OPENED THE DEVICE AND REAPPLIED TO SMALLER AMOUNT OF TISSUE AND STILL NO BURN. THE STAFF THEN CONTACTED ME AND ADVISED ON THE SITUATION AND I SAID THEY COULD THEN OPEN A NEW DEVICE. THEY TRIED A SECOND DEVICE AND THE SAME THING HAPPENED. BUT THEY CHARGED THE PATIENT FOR THIS ONE. HAD THE SAME LOT NUMBER AS THE FIRST DEVICE. WAS A VERY SICK PATIENT WHO WAS BLEEDING, SO SURGEON REVERTED TO AN OPEN PROCEDURE. I DID ADVISE THE STAFF MEMBER TO PLEASE KEEP ME THE FAULTY DEVICE SO I COULD SEND IT FOR PRODUCT COMPLAINT. I ALSO SPOKE TO THE STOCK CONTROLLER AND ASKED HIM TO PLEASE ADVISE THE STAFF TO KEEP THE DEVICE. BUT WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318692 ↗
• 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 ↗
• MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: WITH THE FIRST INSTRUMENT, THE COAGULATION CYCLE STOPPED, AND THE SURGEON HAD TO REPLACE IT. THE SAME PROBLEM OCCURRED WITH THE SECOND INSTRUMENT. THE SURGEON THEN USED A [COMPETITOR DEVICE] TO COMPLETE THE SURGERY. IN TOTAL, THREE INSTRUMENTS WERE USED (2 VOYANTS + 1 [COMPETITOR DEVICE]). THE SURGEON EXPRESSED CONCERNS ABOUT THE ADDITIONAL COST FOR BOTH THE PATIENT AND THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23OCT25: LAPAROTOMY FOR CANCER: DOING VERY WELL, STILL HOSPITALIZED, EXPECTED TO BE DISCHARGED THIS WEEK. NO INTRAOPERATIVE (BLEEDING) OR POSTOPERATIVE COMPLICATIONS. NO, I MANAGED TO OPEN THE JAWS, BUT THE COAGULATION CYCLE STOPPED AND THE JAWS DID NOT OPEN PROPERLY. IN THE END, THE SCRUB NURSE COULD NOT OPEN THE JAWS. OMENTUM. NOT VERY THICK. THE PATIENT DID NOT HAVE ANY VASCULAR PATHOLOGY OR WAS THE DEVICE ACTIVATED ON DISEASED OR INFLAMED TISSUE (CALCIFIED, SCARRED, ATHEROSCLEROTIC, FIBROTIC, ETC.). NO TENSION APPLIED TO A VESSEL OR TISSUE BUNDLE DURING SEALING. VERY SHORT TIME, LESS THAN 5 MINUTES (5¿8 ACTIVATIONS?). NO, NOT MORE THAN USUAL ESCHAR BUIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562478 ↗
• MalfunctionNov 14, 2025Mechanical Problem; Mechanical Problem

  PROCEDURE PERFORMED: LAPAROTOMY FOR CANCER. EVENT DESCRIPTION: WITH THE FIRST INSTRUMENT, THE COAGULATION CYCLE STOPPED, AND THE SURGEON HAD TO REPLACE IT. THE SAME PROBLEM OCCURRED WITH THE SECOND INSTRUMENT. THE SURGEON THEN USED A [COMPETITOR DEVICE] TO COMPLETE THE SURGERY. IN TOTAL, THREE INSTRUMENTS WERE USED (2 VOYANTS + 1 [COMPETITOR DEVICE]). THE SURGEON EXPRESSED CONCERNS ABOUT THE ADDITIONAL COST FOR BOTH THE PATIENT AND THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23OCT25: LAPAROTOMY FOR CANCER: DOING VERY WELL, STILL HOSPITALIZED, EXPECTED TO BE DISCHARGED THIS WEEK. NO INTRAOPERATIVE (BLEEDING) OR POSTOPERATIVE COMPLICATIONS. NO, I MANAGED TO OPEN THE JAWS, BUT THE COAGULATION CYCLE STOPPED AND THE JAWS DID NOT OPEN PROPERLY. IN THE END, THE SCRUB NURSE COULD NOT OPEN THE JAWS. OMENTUM. NOT VERY THICK. THE PATIENT DID NOT HAVE ANY VASCULAR PATHOLOGY OR WAS THE DEVICE ACTIVATED ON DISEASED OR INFLAMED TISSUE (CALCIFIED, SCARRED, ATHEROSCLEROTIC, FIBROTIC, ETC.). NO TENSION APPLIED TO A VESSEL OR TISSUE BUNDLE DURING SEALING. VERY SHORT TIME, LESS THAN 5 MINUTES (5¿8 ACTIVATIONS?). NO, NOT MORE THAN USUAL ESCHAR BUILD UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562457 ↗

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