PDS D8978Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031031753), received between Nov 21, 2023 and May 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, ONLY ONE OUT OF EIGHT NEEDLES WAS DISCOLORED. IT WAS 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 25299155 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR REMOVAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN EASILY DURING INTERRUPTED SUTURE ON SUBCUTANEOUS DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454053 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR REMOVAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN EASILY DURING INTERRUPTED SUTURE ON SUBCUTANEOUS DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454044 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR REMOVAL PROCEDURE ON (B)(6). 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN EASILY DURING INTERRUPTED SUTURE ON SUBCUTANEOUS DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453982 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMORECTOMY ON 25-OCT-2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS MISSING, AND THERE WAS RESISTANCE WHEN THE NEEDLE WAS ABOUT TO STICK THE TISSUE, AND THE NEEDLE DID NOT STICK THE TISSUE, SO ANOTHER PACK OF THE PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. USUALLY, THE NEEDLE SHOULD BE TAPERED TOWARD THE NEEDLE TIP, BUT THE SURGEON FELT THAT THE SHAPE FELT UNUSUAL. WHEN THE NEEDLE TIP WAS CHECKED TO SEE IF IT FELL INTO THE PATIENT'S BODY OR ON THE SURROUNDING AREA OR THE FLOOR, IT WAS NOT FOUND. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182121 ↗