PDS Z510GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031061330), received between Jun 25, 2021 and Feb 11, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLE AND THE SUTURE HAD BEEN DETACHED AND COULD NOT BE USED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316666 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT STUCK IN THE DERMAL DURING DERMAL SUTURE. IT WAS DIFFICULT TO PASS THE NEEDLE THROUGH FROM THE FIRST STITCH. WHEN THE SURGEON CHECKED THE NEEDLE AND FOUND IT HAD A SCRATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113777 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2022 AND THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089270 ↗
• MalfunctionJun 25, 2021Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PTOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS REPORTED TO BE TORN/FRAYED/CURLED DURING USE ON THE DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12069791 ↗