1 Uni Pdo 45cm VLP-2014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848782020850), received between Sep 9, 2025 and Aug 10, 2026 — classified as 3 injuries, 2 malfunctions.

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

• InjuryAug 10, 2026Break

  It was reported on (b)(6) 2026, that during a laparoscopic total hysterectomy, the suture broke intraoperatively resulting in bleeding at the incision site. The suture was replaced, and the incision was resutured. No additional injuries or complications reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50196240 ↗
• InjuryAug 10, 2026Break

  It was reported on(b)(6) 2026, that during a laparoscopic total hysterectomy, the suture broke intraoperatively resulting in bleeding at the incision site. The suture was replaced, and the incision was resutured. No additional injuries or complications reported.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50195343 ↗
• MalfunctionMay 6, 2026Separation Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING USE THE NEEDLE DETACHED FROM THE SUTURE, FELL INTO THE PATIENT, AND WAS SUCCESSFULLY RETRIEVED. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097619 ↗
• MalfunctionMay 6, 2026Separation Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING USE THE NEEDLE DETACHED FROM THE SUTURE, FELL INTO THE PATIENT, AND WAS SUCCESSFULLY RETRIEVED. NO PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096047 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT DURING THE OPERATION, THE PATIENT DEHISCED. THE SURGEON RE-SUTURED WITH OTHER ABSORBABLE SUTURES TO CLOSE THE INCISION. NO OTHER INTERVENTION REQUIRED.

  Patient problems: Wound Dehiscence

  MAUDE report 23003602 ↗