ETHICON SECURESTRAP STRAP25Recalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 10705031132993), received between Dec 1, 2017 and Sep 17, 2026 — classified as 17 injuries, 312 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (159 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 25 most recent of 329 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Misfire

  Device misfired.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801917 ↗
• MalfunctionAug 17, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286607 ↗
• MalfunctionAug 12, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222052 ↗
• MalfunctionAug 7, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. It was reported that total 4 products occurred suture breakage issue when the surgeon attempted to sew the tissue. Changed another one to complete the surgery. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50182042 ↗
• MalfunctionJul 27, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009650 ↗
• MalfunctionMay 22, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2026 AND ABSORBABLE STRAP WAS USED. A NEW SECURESTRAP WAS REMOVED FROM ITS PACKAGING USING STERILE TECHNIQUE AND INSERTED INTO THE PATIENT'S ABDOMEN FOR USE IN A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. THE DEVICE WAS FIRED AND IT WAS OBSERVED THAT THIS FIRST STRAP WHICH WAS INSERTED INTO TISSUE HELD THE MESH IN PLACE. WITH THE SECOND FIRING OF THE DEVICE, IT WAS OBSERVED THAT THIS SECOND STRAP DID NOT INSERT FULLY INTO THE TISSUE AS THE POINTY EDGES ON EITHER SIDE OF THE STRAP LEGS WERE VISIBLE ABOVE THE TISSUE AND MESH. THE DEVICE WAS FIRED A THIRD TIME AND IT WAS AGAIN OBSERVED THAT THE POINTY EDGES OF THIS THIRD STRAP WERE ALSO VISIBLE. THE SECURESTRAP DEVICE WAS REMOVED FROM THE ABDOMEN AND THE DEVICE WAS FIRED ON THE SCRUB NURSE TECHNICIAN'S TABLE MULTIPLE TIMES TO DETERMINE FUNCTIONALITY OF THE DEVICE. THE STRAPS WERE NOT DEPLOYED FROM THE DEVICE AS EASILY AS THEY ARE DESIGNED TO FUNCTION; THE DEVICE WAS DIFFICULT TO FIRE WHEN WHEN THE FIRING HANDLE WAS ENGAGED MULTIPLE TIMES. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255606 ↗
• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. THE ABSORBABLE STRAP MATERIAL HAD STAPLES THAT WERE LOOSE AND FELL OUT OF THE STAPLER. ANOTHER UNIT OF THE SAME MATERIAL WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229335 ↗
• MalfunctionMay 1, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WAS USED. PROCEDURE INGUINAL HERNIA BY LAPAROSCOPY "IN BILATERAL INGUINAL HERNIORRHAPHY SURGERY, DURING THE INTERVENTION ON THE RIGHT SIDE THE DOCTOR WAS GOING TO BEGIN TO FIX THE MESH WITH THE ABSORBABLE STRAP AND THE HOOKS DID NOT COME OUT, AFTER THREE ATTEMPTS THE STAPLES BEGAN TO COME OUT, BUT THEY DID NOT FIX THE MESH, THEY DID NOT TAKE THE LIGAMENT (IN THE PURPOSE OF FIXING IT SEVERAL STAPLES WERE LOST) UNTIL SOME OF THEM FIXED BUT THE STAPLES HAD ALREADY RUN OUT. THE SECURESTRAP 25. I HAD TO PASS A SECURESTRAP 12 TO BE ABLE TO FIX THE MESH, I NOTICED THAT THE GRIP OF THE STAPLES WAS BETTER ON THE 12 STRAP AND IT HAD NO OBSTACLES WHEN FIRING THE STAPLES. THE EVENT OCCURS DURING THE USE OF THE MEDICAL DEVICE; IT DID NOT CAUSE HARM TO PATIENT. THERE WERE NO SIGNIFICANT DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057204 ↗
• MalfunctionApr 20, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. STAPLER HAD A DEFECT, WITH A STAPLE FAILURE, EVEN THOUGH IT WAS "STRAIGHT", A STAPLE FIXATION DEFECT. A SECOND STAPLER WAS USED, WHICH WAS SUCCESSFUL TO COMPLETE THE SURGERY. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929212 ↗
• MalfunctionApr 20, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WAS USED. DURING STAPLE FIXATION, THE STAPLER JAMMED AFTER MULTIPLE ATTEMPTS. IT RELEASED SEVERAL CLIPS IN SUCCESSION, BUT THEY DID NOT ATTACH TO THE ABDOMINAL WALL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925111 ↗
• MalfunctionApr 15, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. THE CUSTOMER IS INFORMED THAT THE DEVICE DOES NOT APPLY THE FASTENERS CORRECTLY AND JAMS AT THE TIME OF THE TRIP. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886839 ↗
• MalfunctionApr 13, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP VENTRAL HERNIA PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. THE DEVICE DID NOT WORKED WHILE USING INTRA-OP PROCEDURE OR WHILE HERNIA MESH FIXATION TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859685 ↗
• MalfunctionApr 10, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. THE SECURESTRAP CLAMP JAMS THE EXIT OF THE TACKERS AND WHEN THEY COME OUT THEY ARE NOT FIXED TO THE FABRIC OR WALL WHERE IT IS REQUIRED, THEREFORE THE MESH IS LOOSE AND IT IS TIME TO PASS ANOTHER 25 MM CLAMP. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844612 ↗
• MalfunctionApr 8, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WAS USED. DEFECTIVE DEVICE. EITHER THE STAPLES DID NOT COME OUT, OR THEY CAME OUT THROUGH 2 AND DID NOT ATTACH TO THE PROSTHESIS. WASTE OF TIME. DEVICE CHANGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817078 ↗
• MalfunctionApr 7, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. AFTER TRYING TO APPLY THE SECURE STRAP TACKS, THE TACKS WERE NOT ABLE TO SECURE THE MESH, THEY OPENED ANOTHER SECURESTRAP AND THE DEVICE OPERATED AS INTENDED. THEY WERE ABLE TO OPEN A NEW DEVICE AND COMPLETE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802991 ↗
• MalfunctionApr 7, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. AFTER TRYING TO APPLY THE SECURE STRAP TACKS, THE TACKS WERE NOT ABLE TO SECURE THE MESH, THEY OPENED ANOTHER SECURESTRAP AND THE DEVICE OPERATED AS INTENDED. THEY WERE ABLE TO OPEN A NEW DEVICE AND COMPLETE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802966 ↗
• MalfunctionMar 30, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. DURING THE PROCEDURE FOR A BILATERAL INGUINAL HERNIA IN A PATIENT, THE STAPLES DID NOT PENETRATE INTO THE HARD PLANE AND FELL, FOR 4 STAPLES IN A ROW. THEN, THE CLIP DID NOT COME OUT OF THE CLAMP AT ALL. THE SURGEON PULLED OUT THE FORCEPS TO TRY TO MAKE IT WORK AGAIN BUT IT WAS BLOCKED WITH NO WAY TO PULL OUT A STAPLE. TO COMPLETE THE PROCEDURE, ANOTHER CLAMP HAD TO BE OPENED. THERE WERE NO CLINICAL CONSEQUENCES EXCEPT FOR LOSS OF TIME AND FINANCIAL LOSS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735900 ↗
• MalfunctionMar 11, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. MULTIPLE SHOTS DO NOT HOLD OR LEAVE THE APPLICATOR, JAMMING OR FIRING MORE AT THE NEXT SHOT. HCP REPORTS DIFFICULTY FIXING NETWORKS IN THE COOPER LIGAMENT WHEN IT HAS ALWAYS DONE SO WITHOUT PROBLEMS IN THE PAST. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575120 ↗
• MalfunctionMar 4, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. DURING THE MESH FIXATION BY THE ABSORBABLE STRAPS EIGHT STRAP WAS USED BUT REMAINING ARE NOT WORK AND DIDN'T FIRED IN TO THE MESH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512906 ↗
• MalfunctionMar 4, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. DURING THE MESH FIXATION BY ABSORBABLE STRAP EIGHT STRAP WAS USED BUT REMAINING ARE NOT WORK AND DIDN'T FIRE IN TO THE MESH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506449 ↗
• MalfunctionFeb 26, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. THE PINS IN THE STRAP WERE NOT FIRING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456935 ↗
• MalfunctionFeb 25, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND ABSORBABLE STRAPS WERE USED. AFTER TRYING TO APPLY THE SECURE STRAP TACKS, THE TACKS WERE NOT ABLE TO SECURE THE MESH, THEY OPENED ANOTHER SECURESTRAP AND THE DEVICE OPERATED AS INTENDED. THEY WERE ABLE TO OPEN A NEW DEVICE AND COMPLETE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442844 ↗
• MalfunctionFeb 18, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND ABSORBABLE STRAPS WERE USED. DURING USE, THE MATERIAL MALFUNCTIONED, FAILING TO STAPLE AND RENDERING IT UNUSABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379252 ↗
• MalfunctionJan 9, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. THE ABSORBABLE STRAP DID NOT STAPLE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023198 ↗
• MalfunctionJan 7, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND ABSORBABLE STRAPS WERE USED. DURING A LAPAROSCOPIC HERNIA REPAIR, THE SURGEON OPENED A SECURE STRAP TO FIX HER REPAIR. THERE WAS A PROBLEM WITH THE MECHANISM AND DEPLOYMENT. THE STAPLE WAS COMING OUT OF THE DEVICE BUT DID NOT COMPLETE ITS FIXATION ACTION. THERE WAS NO SIGNIFICANT DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993971 ↗

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