NA 013593Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010025043), received between Dec 9, 2020 and Jun 19, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE PROTECTIVE SLEEVE AT THE TIP OF A SUTURE RETRIEVER HAD COME OFF AND THE POUCH WAS DAMAGED. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293590 ↗
• MalfunctionJan 5, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE RETRIEVER WIRE COULD NOT COME OUT OF THE SUTURE RETRIEVER. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117545 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SUTURE RETRIEVED TIP OF THE LOOP WAS FRAYED WHEN THE PACKAGE WAS OPENED. IT BROKE IMMEDIATELY WHEN IT WAS USED. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE. NO DELAY WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976987 ↗