PDS D8252Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031029644), received between Feb 21, 2018 and Dec 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAS DETACHED DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756765 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN IT WAS USED TO SUTURE DERMIS. THE DOCTOR DID NOT APPLY THE FORCE MUCH. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084711 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SWAGE PART OF THE NEEDLE WAS EASY TO GET CAUGHT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367037 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. THE NEEDLE WAS BROKEN DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291690 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. THE NEEDLE WAS BROKEN DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291673 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. THE NEEDLE WAS EASILY BENT AND BROKEN AT THE TIP DURING DERMOSTITCH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196788 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. THE NEEDLE WAS EASILY BENT AND BROKEN AT THE TIP DURING DERMOSTITCH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196783 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BONE GRAFTING PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THE NEEDLE HAD BEEN UNUSUALLY BENT WHEN OPENING THE PACKAGE. THE NEEDLE WAS BROKEN AT THE MIDDLE WHEN THE SURGEON TRIED TO FIX IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7905436 ↗
• MalfunctionFeb 21, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MAMMECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT SEVERAL LOCATIONS DURING DERMOSTITCH BY INTERRUPTED SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287902 ↗