ETHICON SECURESTRAP STRAP12RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031470576), received between Dec 11, 2025 and Mar 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K093845); they may or may not involve this specific model.

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.

• MalfunctionMar 5, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. DURING AN UNKNOWN PROCEDURE, THE STRAP WAS FALLEN OFF. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER DEVICE 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 24522011 ↗
• MalfunctionDec 11, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. AFTER DEPLOYING STRAPS A FEW TIMES, IT BECAME A LITTLE LOOSE AND THE STRAP FELL OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093845. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2011 · Dec 29, 2010 · Terminated
  Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open