ETHICON SECURESTRAPRecalls & reported problems across all models

We found 6 models of ETHICON SECURESTRAP by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 442 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2017 and Sep 30, 2026 — classified as 20 injuries, 422 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (224 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ETHICON SECURESTRAP problems

ETHICON SECURESTRAP models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ETHICON SECURESTRAP STRAP25

  STAPLE, IMPLANTABLE
  329 reports
• ETHICON SECURESTRAP STRAP12

  STAPLE, IMPLANTABLE
  98 reports
• ETHICON SECURESTRAP STRAP25R

  Staple, implantable
  7 reports
• ETHICON SECURESTRAP OPENSTRAP20

  STAPLE, IMPLANTABLE
  3 reports
• ETHICON SECURESTRAP OPSTRAP20

  STAPLE, IMPLANTABLE
  3 reports
• ETHICON SECURESTRAP STRAP12R

  Staple, implantable
  2 reports

Recent ETHICON SECURESTRAP adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 24, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890326 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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