Uni 3-0 Mono 20cm VLM-1008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848782020133), received between Sep 13, 2024 and May 20, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Separation Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT A NEEDLE DETACHED FROM THE SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO REMOVE THE NEEDLE FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232066 ↗
• MalfunctionMay 15, 2026Separation Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT A NEEDLE DETACHED FROM THE SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO REMOVE THE NEEDLE FROM THE PATIENT. NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183996 ↗
• MalfunctionApr 22, 2026Separation Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT A NEEDLE DETACHED INTRA-OPERATIVELY, FELL INTO THE PATIENT AND WAS SUCCESSFULLY RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958946 ↗
• InjuryOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON 18 OCTOBER 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED, AND THE NEEDLE WAS RETRIEVED AND REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537144 ↗
• InjurySep 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE WAS BENT AND RESULTED IN A SUTURE BREAKING INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, THERE WAS A SIGNIFICANT PROCEDURAL DELAY TO RETRIEVE AND REPLACE THE BROKEN SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217408 ↗