STRATAFIX SXPP1B415Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031235885), received between Dec 5, 2017 and Dec 18, 2025 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (15 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, 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE TIP EXHIBITED BENDING DURING TISSUE PENETRATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837125 ↗
• MalfunctionNov 11, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. HAD TO PULL OUT THE FIRST BARBED SUTURE AS THE LOOP DIDN'T TIGHTEN ONCE HE¿D THROWN HIS SUTURES IN A BARIATRIC CASE. OUTCOME: PROBABLY ADDED A FEW MINUTES ONTO THE PROCEDURE AND A BIT FRUSTRATING BUT NO HARM CAME TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524835 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREAD BREAKS IN THE MIDDLE AGAIN AND AGAIN WITHOUT STRONG PULLING AFTER 2-3 TISSUE PASSAGES. PERITONEUM WAS SWEN. NEEDLE WAS HOLD IN NEEDLE HOLDER. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME AS DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951096 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREAD BREAKS IN THE MIDDLE AGAIN AND AGAIN WITHOUT STRONG PULLING AFTER 2-3 TISSUE PASSAGES. PERITONEUM WAS SWEN. NEEDLE WAS HOLD IN NEEDLE HOLDER. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME AS DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951094 ↗
• MalfunctionJul 30, 2025Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE SURGERY IT WAS NOTICED THAT AFTER THE PERITONEUM WAS SUTURED, HALF OF THE SUTURE CAME LOOSE AGAIN. A SECOND SUTURE WAS USED TO CLOSE THE REMAINDER. THE REST OF THE SUTURE WAS REMOVED BECAUSE IT DID NOT HOLD. THIS REMAINING THREAD WILL BE RETURNED. OVERALL, THE THREAD APPEARED SMOOTHER THAN USUAL, NO HOOKS VISIBLE. NO PATIENT HARM OR SURGICAL DELAY HAVE BEEN REPORTED. HCP IS AFRAID THAT THE PROBLEM COULD HAPPEN IN THE GYN SURGERY WHEN THE VAGINA IS SEWN UP DURING TLH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662924 ↗
• MalfunctionJul 30, 2025Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE SURGERY IT WAS NOTICED THAT AFTER THE PERITONEUM WAS SUTURED, HALF OF THE SUTURE CAME LOOSE AGAIN. A SECOND SUTURE WAS USED TO CLOSE THE REMAINDER. THE REST OF THE SUTURE WAS REMOVED BECAUSE IT DID NOT HOLD. THIS REMAINING THREAD WILL BE RETURNED. OVERALL THE THREAD APPEARED SMOOTHER THAN USUAL, NO HOOKS VISIBLE. NO PATIENT HARM OR SURGICAL DELAY HAVE BEEN REPORTED. HCP IS AFRAID THAT THE PROBLEM COULD HAPPEN IN THE GYN SURGERY WHEN THE VAGINA IS SEWN UP DURING TLH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662923 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED A CONSULTANT OBSTETRICS HAD MAJOR ISSUES WITH BARBES SUTURE. IT WAS REPORTED THAT 2 NEEDLE TIPS BENT. 1 NEEDLE SNAPPED IN HALF IN THE TISSUE. 1 SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194532 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED A CONSULTANT OBSTETRICS HAD MAJOR ISSUES WITH BARBES SUTURE. IT WAS REPORTED THAT 2 NEEDLE TIPS BENT. 1 NEEDLE SNAPPED IN HALF IN THE TISSUE. 1 SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194531 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE THREAD BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622218 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC ASSISTED INGUINAL HERNIA REPAIR ON (B)(6)2023 AND BARBED SUTURE WAS USED. WHEN USING THE SUTURE TO HELP SECURE A PIECE OF HERNIA MESH THE FIXATION LOOP AT THE END OF THE SUTURE PULLED APART. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278528 ↗
• MalfunctionDec 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE PASSED THROUGH 5MM TROCAR AND NEEDLE SNAPPED OFF FROM SUTURE. SUTURE HELD BY NEEDLE HOLDER AT ABOUT MID POINT OF SUTURE WHEN PASSING THROUGH AND NORMALLY PASSES THROUGH EASILY. THE SUTURE SNAPPED ON 2 X SUTURES FROM THE SAME BOX OF SUTURE HOWEVER ONLY ONE SUTURE AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266217 ↗
• MalfunctionDec 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE PASSED THROUGH 5MM TROCAR AND NEEDLE SNAPPED OFF FROM SUTURE. SUTURE HELD BY NEEDLE HOLDER AT ABOUT MID POINT OF SUTURE WHEN PASSING THROUGH AND NORMALLY PASSES THROUGH EASILY. THE SUTURE SNAPPED ON 2 X SUTURES FROM THE SAME BOX OF SUTURE HOWEVER ONLY ONE SUTURE AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266199 ↗
• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE CUT OFF WHILE USING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962050 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DR. PERFORMS THE CLOSURE OF THE VAGINAL DOME WITH ONE-WAY STRAFIX AND IN THE MIDDLE OF THE CLOSURE THE SUTURE IS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733901 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE DOCTOR FROM OBGYN IN PANTAI IPOH WAS PERFORMING A LAP MYOMECTOMY AND WHEN SHE WAS ABOUT TO CLOSE SHE USED THE BARBED SUTURE AND THE NEEDLE BROKE IN HALF, AND WAS LODGED INSIDE THE TISSUE, SHE REMOVED IT WITH SOME DIFFICULTIES AND USED ANOTHER SIZE BARBED SUTURE, THE NEEDLE BENT DURING THE PROCEDURE, SHE THEN USED ANOTHER SUTURE AND WAS ABLE TO CLOSE THE WOUND. THE PATIENT WAS OK AND RECOVERED WELL. THE SURGERY WAS PROLONGED 20 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362243 ↗
• InjuryMar 9, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. THE PATIENT WAS STABLE TO DAY 6. ON POST-OP DAY 6, THE PATIENT HAD A BIG PAIN. THE PATIENT CAME BACK TO THE HOSPITAL AND UNDERWENT REOPERATION AS A REVISION WAS REQUIRED. THE ANASTOMOSIS WAS REOPENED. THE SURGEON, AFTER CLEANING, CLOSED THE HOLE WITH A DIFFERENT SUTURE. AFTER THE SECOND EMERGENCY SURGERY, THE PATIENT STAYED 9 DAYS IN THE HOSPITAL AND IS NOW STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pain; Wound Dehiscence

  MAUDE report 16513815 ↗
• MalfunctionSep 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO READ THE QR CODE ON THE SUTURE PACKAGING. IT WAS NOTED THAT THE PROBLEM WAS NOT WITH THE READER, BUT IN THE QUALITY OF PRINTING THE QR CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499644 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE TISSUE WAS TORN AT THE GJ ANASTOMOSIS AND THE SURGEON OPINES THAT IT IS ASSOCIATED WITH THE BARBED SUTURE. THE PATIENT REQUIRED REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15166870 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE THE TISSUE WAS TORN AT THE GJ ANASTOMOSIS AND THE SURGEON OPINES THAT IT IS ASSOCIATED WITH THE BARBED SUTURE. THE PATIENT REQUIRED REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15166756 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE TISSUE WAS TORN AT THE GJ ANASTOMOSIS AND THE SURGEON OPINES THAT IT IS ASSOCIATED WITH THE BARBED SUTURE. THE PATIENT REQUIRED REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15166716 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A CLINICAL TRIAL THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY ON (B)(6) 2022 AND BARBED SUTURE WAS USED FOR STAPLE LINE REINFORCEMENT. THE PATIENT DEVELOPED LOCAL PERITONITIS UPPER ABDOMEN WITH SUTURE INSUFFICIENCY, RENEWED OPERATION WITH LAVAGE AND ABSCESS ON THE SPLEEN. ADVERSE EVENT TERM: LOCAL PERITONITIS UPPER ABDOMEN WITH SUTURE INSUFFICIENCY START DATE: (B)(6) 2022. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO. REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES. ADMISSION DATE: BLANK. RESULTED IN MEDICAL OR SURGICAL INTERVENTION: YES. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. INTERVENTION/TREATMENT: DIAGNOSTIC INTERVENTION: YES. ASPIRATION/DRAINAGE: YES. CULTURE TAKEN: YES. INJECTED MEDICATION: YES. OBSERVATION: YES. OUTCOME: RECOVERING/RESOLVING. ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED: NO. ADVERSE EVENT TERM: RENEWED OPERATION WITH LAVAGE START DATE: (B)(6) 2022. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO. REQUIRED IN-PATIENT HOSPITALIZATIO

  Patient problems: Abscess; Peritonitis

  MAUDE report 14310990 ↗
• InjuryApr 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AND THE NEEDLE STUCK INTO THE TISSUE. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN AND CONVERTED FROM LAP TO AN OPEN PROCEDURE. THE SURGERY DELAY WAS ABOUT 30 MINUTES. THE NEEDLE HAS BEEN REMOVED FROM PATIENT DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14073533 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE REINFORCING THE STOMACH NEAR THE GE JUNCTION, THE SUTURE SNAPPED UNDER ROBOTIC TENSION AND NEEDED TO BE RETRIEVED FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238611 ↗
• MalfunctionJul 30, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BY-PASS PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE CLOSING THE OPENING OF THE STOMA, THE SPIRALS IN THE BODY OF THE SUTURE WERE NOT GRASPING ENOUGH TISSUE AND AT THE END OF THE SECOND CLOSING PASSAGE, THE SUTURE JUST REOPENED PARTIALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253137 ↗
• MalfunctionMar 3, 2021Material Integrity Problem; Migration; Material Integrity Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE THREAD DID NOT RESORBED AND WAS REJECTED BY THE BODY WHEN SEEN BY SURGEON 1 MONTH AFTER THE SURGERY. THE IMPACT TO THE WOUND WAS BAD SCARRING AND THE DURATION OF POST-OP BLEEDING. NO SERIOUS CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Pocket Erosion; Scar Tissue

  MAUDE report 11408590 ↗