2-0 Uni Pdo 20cm VLP-2006Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00848782020751), received between Jul 3, 2024 and May 20, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231714 ↗
• MalfunctionJan 26, 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 24178695 ↗
• MalfunctionNov 24, 2025Separation Problem; Separation Problem

  IT WAS REPORTED ON (B)(6) 2025 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 23633677 ↗
• InjurySep 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2025 THAT DURING THE OPERATION, THE NEEDLE BROKE AND FELL INTO THE PATIENT. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED.

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

  MAUDE report 23030583 ↗
• InjuryAug 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY AND FELL INTO THE PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 22890674 ↗
• InjuryApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLE FROM THE PATIENT. NO OTHER INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875731 ↗
• InjuryApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLE FROM THE PATIENT. NO OTHER INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875459 ↗
• InjuryApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLE FROM THE PATIENT. NO OTHER INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875452 ↗
• InjuryDec 13, 2024Separation Problem; Separation Problem

  IT WAS REPORTED ON (B)(6) 2024, THAT DURING A SURGICAL PROCEDURE THE NEEDLE DETACHED FROM THE THREAD CAUSING A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929477 ↗
• InjuryNov 27, 2024Separation Problem; Separation Problem

  IT WAS REPORTED ON 13 NOV 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL DELAY, AND INTERVENTION WAS NEEDED TO RETRIEVE THE NEEDLE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800300 ↗
• InjuryNov 27, 2024Separation Problem; Separation Problem

  IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL DELAY, AND INTERVENTION WAS NEEDED TO RETRIEVE THE NEEDLE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800282 ↗
• InjuryOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY. NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED, WHICH RESULTED IN A SIGNIFICANT PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360019 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE WAS RETRIEVED WITH NO ADDITIONAL INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934807 ↗
• MalfunctionJul 10, 2024Separation Problem; Separation Problem

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE THE NEEDLE DETACHED AND WAS REMOVED IMMEDIATELY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715745 ↗
• MalfunctionJul 3, 2024Separation Problem; Separation Problem

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE THE NEEDLE FELL AND NEEDED TO BE REMOVED PROLONGING PATIENT SURGERY TIME AND INCREASED PAIN AND DAYS OF HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Pain

  MAUDE report 19671784 ↗