ETHICON SECURESTRAP STRAP12Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10705031132986), received between Jan 10, 2018 and Sep 24, 2026 — classified as 98 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (57 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 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890326 ↗
• MalfunctionJul 20, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25875007 ↗
• MalfunctionJun 19, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAP WAS USED. AT THE TIME OF FIXING THE MESH THE HOOK DOES NOT WORK AND IS RELEASED, THIS SITUATION OCCURS TWICE CONSECUTIVELY, ON A THIRD TIME HE GRABS THE HOOK AND ON A FOURTH TIME THE HOOK IS RELEASED. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560603 ↗
• MalfunctionApr 2, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. IN INGUINAL HERNIA SURGERY, AT THE TIME OF FIXING THE MESH WITH THE SECURESTRAP TACKERS, THEY WERE NOT FIXED AND THEREFORE A TOTAL OF THREE SECURESTRAP FORCEPS WERE REQUIRED FOR THE PROCEDURE 12. THERE IS NO SAMPLE. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769164 ↗
• MalfunctionApr 2, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. IN INGUINAL HERNIA SURGERY, AT THE TIME OF FIXING THE MESH WITH THE SECURESTRAP TACKERS, THEY WERE NOT FIXED AND THEREFORE A TOTAL OF THREE SECURESTRAP FORCEPS WERE REQUIRED FOR THE PROCEDURE 12. THERE IS NO SAMPLE. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769158 ↗
• MalfunctionApr 2, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. THE DOCTOR WAS GOING TO ATTACH THE MESH TO THE COOPER AND THE SECURESTRAP DID NOT STAPLE THE FABRIC DID NOT FIX, SEVERAL SHOTS WERE FIRED AND NONE FIXED. ANOTHER SECURESTRAP IS REQUESTED TO SECURE THE MESH AND CLOSE THE FLAP. THERE WERE NO SIGNIFICANT DELAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766150 ↗
• MalfunctionDec 8, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND ABSORBABLE STRAPS WERE USED. THE DEVICE COULDN'T APPLIED ANY STRAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750713 ↗
• MalfunctionDec 8, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6)2025 AND ABSORBABLE STRAPS WERE USED. THE DEVICE WAS NOT EFFECTIVE AND NOT PROPERLY DISCHARGING TACKERS DURING SURGERY. NO PATIENT CONSEQUENCE IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749066 ↗
• MalfunctionOct 20, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. WHEN PERFORMING THE SEVENTH SHOT FOR FIXING THE SCREEN, THE STAPLER STUCK AND SHOWED RESISTANCE, NOT STAPLING THE SCREEN. AFTER TWO UNSUCCESSFUL ATTEMPTS, THE SURGEON CHOSE NOT TO USE THE MATERIAL ANYMORE AND FINISHED THE PROCEDURE WITH SUTURE. THAT IS, AFTER THE SEVENTH SHOT, THE STAPLER CRASHED AND COULD NO LONGER BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341272 ↗
• MalfunctionOct 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNILATERAL INGUINAL HERNIORRHAPHY ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. ONLY 9 HOOKS CAME, AND THE ONES HE HAD DID NOT HOLD THE FABRIC, SO THE DEVICE FAILED. ANOTHER DEVICE WAS PLACED. THOSE RESPONSIBLE FOR THE SECURITY EVENT WERE INFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY OR FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT EVENTS ASSOCIATED WITH THE PROBLEM WITH THE MEDICAL DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203981 ↗
• MalfunctionAug 28, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. THE DEVICE WAS NOT PERFORMING. THE TRIGGER WORKED BUT PINS DIDN'T ADHERED TO TISSUE, IN BETWEEN ONLY 4 PINS ADHERED. THERE WAS NO PATIENT ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913495 ↗
• MalfunctionMay 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. WHEN STAPLES ARE APPLIED TO THE FABRIC, THE CORRESPONDING SHOTS ARE FIRED, BUT THEY DO NOT GRASP THE FABRIC, CAUSING THE STAPLES TO COME LOOSE REPEATEDLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039614 ↗
• MalfunctionMay 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. WHEN STAPLES ARE APPLIED TO THE FABRIC, THE CORRESPONDING SHOTS ARE FIRED, BUT THEY DO NOT GRASP THE FABRIC, CAUSING THE STAPLES TO COME LOOSE REPEATEDLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039590 ↗
• MalfunctionMay 15, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. THE DEVICE INITIALLY FIRES FIXATIVES, BUT THE DOCTOR STATES THAT THEY DO NOT FIXATE PROPERLY. AFTER ACTIVATING THEM AGAIN, THE SHOTS DO NOT COME OUT UNTIL THEY FINALLY BECOME BLOCKED. WHEN FIRING THE SHOTS, IT IS NOTICEABLE THAT THE DEVICE IS BLOCKED. FOR THIS REASON, ANOTHER CLAMP IS REQUESTED TO COMPLETE THE SURGICAL PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031343 ↗
• MalfunctionApr 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. THE DOCTOR WAS USING ONE OF THE TACKERS TO SECURE THE MESH. THE ABSORBABLE STRAP FIXATION DEVICE WOULD "FIRE", BUT WOULD NOT STICK OR STAY ON THE MESH. THE DEVICE WAS REMOVED WAS THE FIELD AND REPLACED. NO HARM TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777727 ↗
• MalfunctionMar 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA PROCEDURE ON (B)(6)2025 AND ABSORBABLE STRAPS WERE USED. THE TISSUE WAS NOT ANCHORING PROPERLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692619 ↗
• MalfunctionMar 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND ABSORBABLE STRAPS WERE USED. THE STRAPS WASN¿T ABLE TO PASS THE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691323 ↗
• MalfunctionMar 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6)2025 AND ABSORBABLE STRAPS WERE USED. THE STRAPS WASN¿T ABLE TO PASS THE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691318 ↗
• MalfunctionMar 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6)2025 AND ABSORBABLE STRAPS WERE USED. THE STRAPS WASN¿T ABLE TO PASS THE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691317 ↗
• MalfunctionMar 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GROIN HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. THE STRAPS WERE NOT DEPLOYED TO THE TISSUE PROPERLY AT THE 5-6 FIRING. IT WAS USED ON ABDOMINAL WALL. THE STRAPS GOT CAUGHT IN THE TISSUE. WHEN THE DOCTOR REMOVED THE STAPLES, THERE WAS BLEEDING FROM THAT SPOT AND HEMOSTASIS (ELECTROCAUTERY) WAS PERFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21567520 ↗
• MalfunctionFeb 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC UNKNOWN SURGERY ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. THE DEVICE (100TP8) DID NOT DEPLOY STRAPS AT THE 1ST FIRING, AND HALF OF THE CLIP WAS EJECTED AT FIRST THE 2ND FIRING. ONE CLIP POPPED OUT WHEN AN AIR SHOT WITH THE DEVICE OUTSIDE OF THE SURGICAL FIELD. THE DEVICE (100ESA) ALSO DID NOT DEPLOY STRAPS AT THE 1ST FIRING, AND THE CLIP WAS ADHERING TO THE UPPER ABDOMINAL WALL. IT COULD NOT BE FIXED TO THE ABDOMINAL WALL AT THE 1ST FIRING, BUT IT WAS CONFIRMED THAT THERE WAS BLEEDING FROM THE SITE WHERE IT WAS HIT. THE BLEEDING SITE WAS STOPPED BY AN ELECTRIC KNIFE. THE GRASPING FORCE OF BOTH DEVICES WAS HIGHER THAN EXPECTED. A COMPETITIVE DEVICE WAS USED AS A REPLACEMENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21307125 ↗
• MalfunctionFeb 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC UNKNOWN SURGERY ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. THE DEVICE (100TP8) DID NOT DEPLOY STRAPS AT THE 1ST FIRING, AND HALF OF THE CLIP WAS EJECTED AT FIRST THE 2ND FIRING. ONE CLIP POPPED OUT WHEN AN AIR SHOT WITH THE DEVICE OUTSIDE OF THE SURGICAL FIELD. THE DEVICE (100ESA) ALSO DID NOT DEPLOY STRAPS AT THE 1ST FIRING, AND THE CLIP WAS ADHERING TO THE UPPER ABDOMINAL WALL. IT COULD NOT BE FIXED TO THE ABDOMINAL WALL AT THE 1ST FIRING, BUT IT WAS CONFIRMED THAT THERE WAS BLEEDING FROM THE SITE WHERE IT WAS HIT. THE BLEEDING SITE WAS STOPPED BY AN ELECTRIC KNIFE. THE GRASPING FORCE OF BOTH DEVICES WAS HIGHER THAN EXPECTED. A COMPETITIVE DEVICE WAS USED AS A REPLACEMENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21307120 ↗
• MalfunctionJan 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INGUINAL HERNIORRAPHY ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. IT WAS OBSERVED THAT THE STAPLES DID NOT PENETRATE THE TISSUES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183518 ↗
• MalfunctionJan 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. WHEN FIXING THE MESH WITH THE STRAPS THE DEVICE JAMS AND DID NOT MAKE ANY SHOT, THE STRAPS FELL AND DO NOT FIX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060412 ↗
• MalfunctionDec 31, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. WHEN FIXING THE MESH WITH THE STRAPS, THE GUN STUCK AND DID NOT FIRE ANY SHOTS, THEY FELL AND DID NOT FIX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048514 ↗

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