ETHI-PAK DS26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031036765), received between Feb 14, 2023 and Aug 21, 2025 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN PLASTIC SURGERY, THE DOCTOR SAID THAT RECENTLY THE WIRES HAVE BECOME EASIER TO BREAK ABOUT THE DS26 REGULARLY USES. THE DOCTOR WOULD LIKE TO KNOW IF THERE HAD BEEN ANY CHANGES TO THE PRODUCT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861658 ↗
• MalfunctionFeb 14, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PATIENT BUT WAS NOT STERILIZED. REP STATED FOR SOME REASON, THE ACCOUNT THOUGHT THE DEVICE WAS STERILE. UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WERE ANY ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373311 ↗