Sientra Viality-1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810076894621), received between Jul 6, 2023 and Apr 9, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Suction 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.

• InjuryApr 9, 2026Suction Failure

  TWO VIALITY UNITS HAD SUCTION ISSUES AT THE ONSET OF THE CASE. BACKUP WAS USED TO COMPLETE THE PROCEDURE. THE HEALTHCARE PROVIDER HEARD SOUNDS LIKE THE SEAL IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829945 ↗
• InjuryAug 22, 2024Component Missing; Component Missing

  HEALTHCARE PROVIDER INFORMED SIENTRA THAT THERE WAS NO MESH ON ONE SIDE OF THE VIALITY UNIT'S INTERNAL BASKET. IT WAS COMPLETELY MISSING. ONCE IT WAS REALIZED, THAT PART OF THE MESH BASKET WAS MISSING, EVERYTHING WAS HARVESTED INTO A CANNISTER AND ABORTED THE VIALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028504 ↗
• InjuryAug 5, 2024Crack; Crack

  THE SIDE OF THE VIALITY UNIT CRACKED HORIZONTALLY DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906227 ↗
• MalfunctionJan 12, 2024Suction Problem; Suction Problem

  AFTER USING LIPOSUCTION TO COLLECT FAT INTO VIALITY DEVICE, THE SURGEON PULLED THE DRAWER TO EXPOSE FAT TO SPONGE AND ONLY A SCANT AMOUNT OF FLUID ABSORBED INTO THE SPONGE. THE EXCESS FLUID WOULD NOT SUCTION OUT OF THE VIALITY MACHINE EITHER. THE SURGEON THEN OPENED A SECOND DEVICE AND THE SAME EXACT PROBLEM OCCURRED. SURGEON THEN HAD TO DRY FAT OUT ON LAP SPONGES IN ORDER TO DRY FAT. THIS SURGEON HAS USED VIALITY MULTIPLE TIMES AND HAS NEVER EXPERIENCED THIS BEFORE, PATIENT DID NOT HAVE FIBROUS FAT. THIS RECORD CAPTURES THE SECOND VIALITY UNIT USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503492 ↗
• MalfunctionJan 12, 2024Suction Problem; Suction Problem

  AFTER USING LIPOSUCTION TO COLLECT FAT INTO VIALITY DEVICE, THE SURGEON PULLED THE DRAWER TO EXPOSE FAT TO SPONGE AND ONLY A SCANT AMOUNT OF FLUID ABSORBED INTO THE SPONGE. THE EXCESS FLUID WOULD NOT SUCTION OUT OF THE VIALITY MACHINE EITHER. THE SURGEON THEN OPENED A SECOND DEVICE AND THE SAME EXACT PROBLEM OCCURRED. SURGEON THEN HAD TO DRY FAT OUT ON LAP SPONGES IN ORDER TO DRY FAT. THIS SURGEON HAS USED VIALITY MULTIPLE TIMES AND HAS NEVER EXPERIENCED THIS BEFORE, PATIENT DID NOT HAVE FIBROUS FAT. THIS RECORD CAPTURES THE ORIGINAL VIALITY UNIT USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503369 ↗
• MalfunctionJul 6, 2023Output Problem; Output Problem

  DOCTOR PERFORMED A RE-CONSTRUCTION CASE USING VIALITY AND HE COULD NOT GET SUCTION TO WORK TO THE STRENGTH HE NEEDED IT. THEY TRIED TO PUSH DOWN THE ACCESS CAP AND STILL WERE TOLD NOTHING WAS HELPING. CUSTOMER ENDED UP USING ANOTHER UNIT AND EVERYTHING WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17272991 ↗