ETHICON SECURESTRAP STRAP25RRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031470552), received between Dec 13, 2023 and Sep 30, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and absorbable straps were used. The product clip unable to stay in position. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945845 ↗
• MalfunctionSep 30, 2026Activation Problem

  It was reported that a patient underwent an unknown procedure on an unknonw date and absorbable straps were used. The product clip unable to stay in position. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945842 ↗
• MalfunctionMar 4, 2026Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE STRAPS WERE USED. STAPLE NOT DISPENSING PROPERLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512192 ↗
• MalfunctionJun 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. THE DEVICE COULD NOT FIRE. WHEN THE DOCTOR USED THE FIXATION DEVICE TO FIX THE PATCH DURING SURGERY, THE THIRD OR FOURTH STRAPS COULD NOT BE EFFECTIVELY INSERTED, BUT IT WAS TAKEN OUT OF THE ABDOMINAL CAVITY AND ATTEMPTED TO BE FIRED EXTERNALLY, BUT IT WAS ALSO POWERLESS. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559003 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND SYMBOTEX MESH (MEDTRONIC) WAS SECURED WITH ABSORBABLE STRAPS AND UNSPECIFIED ¿DISPOSABLE STAPLES¿. THE PATIENT IS NOW EXPERIENCING EXTREME PAIN. IT IS NOW 13 WEEKS POST-SURGERY AND SHE IS STILL UNABLE TO FUNCTION NORMALLY. ON (B)(6) 2023, THE PATIENT WAS TREATED FOR INFECTION ON WARD AND THE PIC LINE WAS RULED OUT AS A CAUSE. ON (B)(6) 2024, THE PATIENT UNDERWENT SURGERY TO DRAIN A 31MM SEROMA. ON (B)(6) 2024, ABDOMINAL ULTRASOUND WAS PERFORMED AND REPORTED A SMALL SUPERFICIAL POST-OP SEROMA. ON (B)(6) 2024, O/G PAIN WAS NOTED AND THE HERNIA SURGEON REQUESTED CT ABDO WHICH REPORTED FATTY LIVER, ABNORMAL KIDNEY FUNCTION, NIL SIGN. FINDINGS RELATED TO HERNIA. THE PATIENT REPORTED BLOODWORK WAS NORMAL (FOR HER). ON (B)(6) 2024, THE PATIENT REPORTED ONGOING SIGNIFICANT PAIN (INCL. ON TOUCH) AND BLOATING IN THE MORNING. THE PATIENT SAW THE GP THIS DAY WITH VIEW TO OBTAINING REFERRAL TO SURGEON WHO OPERATED ON HER IN JANUARY FOR SEROMA. THE PATIENT REPORTS THAT SHE DOES NOT WANT TO SEE HER HERNIA SURGEON AS SHE BELIEVES THE SURGEON IS DISMISSIVE OF HER PAIN AND HAS ADVISED THE PATIENT TO CO

  Patient problems: Abdominal Distention; Ecchymosis; Erythema; Pain; Seroma; Unspecified Infection

  MAUDE report 19084221 ↗
• MalfunctionMar 12, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON AN UNKNOWN DATE IN 2024 AND ABSORBABLE STRAPS WERE USED. THE DEVICE WAS FIRED AND THE FIRST 2 TACKERS WERE DEPLOYED AS EXPECTED TO ANCHOR THE MESH IN PLACE. HOWEVER THE THIRD TACKER WHICH WAS DEPLOYED DID NOT PENETRATE THE TISSUE DESPITE THE NOZZLE OF THE DEVICE BEING FLUSH WITH THE TISSUE, THEREAFTER THE FOURTH FIRING DID NOT DEPLOY AND THE FIFTH DEPLOYED 2 TACKS, BOTH OF WHICH DID NOT PENETRATE THE TISSUE. THE SIXTH FIRING DEPLOYED AS EXPECTED UNTIL THE MESH WAS SECURED HOWEVER THE SURGEON REMARKED THAT THERE WERE 3-4 TACKS WASTED. THE SURGEON REMARKED THAT HE IS NOT USED TO THIS LEVEL OF PERFORMANCE FROM THE DEVICE. THERE WAS NO DELAY IN SURGERY. THE STRAPS WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885815 ↗
• MalfunctionDec 13, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE IN 2023 AND ABSORBABLE STRAPS WERE USED TO FIX A COMPETITOR'S MESH. THE DEVICE FIRES A FIXATION CLIP, THEN MISFIRES/ DOESN'T FIRE. THE CLIPS/STRAP DID NOT FIX TO THE ABDOMINAL WALL. COUNTER PRESSURE WAS APPLIED. OPENED 2ND DEVICE AND SUTURED WITH PROLENE. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, BUT SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318980 ↗

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