STRATAFIX SXPP2B423Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031464599), received between Dec 8, 2022 and Aug 18, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50307342 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252631 ↗
• MalfunctionMay 13, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND ENDOCRINE PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING SURGERY, THE SURGEON HAD AN UNUSUAL FEELING AND THE SURGEON FELT THAT IT WAS OBVIOUSLY LESS GRIPPY THAN USUAL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161693 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOW PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE CAME OUT AFTER THE SURGERY. THE SUTURE WAS CUT TO COMPLETE THE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056819 ↗
• MalfunctionMar 26, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND ENDOCRINE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE DID NOT STOP AT THE TRANSITION POINT AND THE BARB WAS WEAK IN TWO CONSECUTIVE CASES. THE SAME PRODUCT WAS USED TO COMPLETE THE CASE BY USING A DOUBLE-ENDED NEEDLE NEAR THE CENTER. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705903 ↗
• MalfunctionMar 24, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND ENDOCRINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE THREAD DID NOT STOP AT THE TRANSITION POINT AND THE BARB WAS WEAK IN TWO CONSECUTIVE CASES. THE SAME PRODUCT WAS USED TO COMPLETE THE CASE BY USING A DOUBLE-ENDED NEEDLE NEAR THE CENTER. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682433 ↗
• MalfunctionMar 24, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AND ENDOCRINE PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE THREAD DID NOT STOP AT THE TRANSITION POINT AND THE BARB WAS WEAK IN TWO CONSECUTIVE CASES. THE SAME PRODUCT WAS USED TO COMPLETE THE CASE BY USING A DOUBLE-ENDED NEEDLE NEAR THE CENTER. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676791 ↗
• MalfunctionMar 17, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) B2026 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE BARB WAS NOT GRIPPING TIGHTLY ENOUGH WHEN THE PRODUCT WAS USED AS USUAL. TWO PRODUCTS FROM THE SAME LOT WERE USED, BUT THE BARBS ON BOTH WERE LOOSE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616617 ↗
• MalfunctionMar 17, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY, THE DOCTOR FELT THAT THE BARB WAS NOT GRIPPING TIGHTLY ENOUGH WHEN THE PRODUCT WAS USED AS USUAL. TWO PRODUCTS FROM THE SAME LOT WERE USED, BUT THE BARBS ON BOTH WERE LOOSE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616615 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, WHEN THE PRODUCT WAS TRIED TO BE USED AND WHILE SUTURING ON THE SURGICAL FIELD, THE SUTURE WAS BROKEN EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819173 ↗
• MalfunctionJun 26, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE AT THE MIDDLE PART WAS BROKEN WHEN THE NEEDLE PASSED THROUGH THE WOUND PART AND THE SUTURE WAS PULLED DURING WOUND CLOSURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336531 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN ALTHOUGH NOT PULLED HARD DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562538 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WITH USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102284 ↗
• MalfunctionApr 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128885 ↗
• MalfunctionApr 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128884 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN IN THE MIDDLE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502159 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839424 ↗
• MalfunctionApr 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BT: BLALOCK-TAUSSIG SHUNT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A BT: BLALOCK-TAUSSIG SHUNT, AFTER TWO STITCHES IN THE DERMIS, THE NEEDLE WAS DETACHED FROM THE SUTURE. ANOTHER PRODUCT WAS USED. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815660 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, BECAUSE THE WOUND DID NOT HEAL EASILY, EPIDERMAL SUTURE WAS PERFORMED WITH NYLON SUTURE. HOWEVER, WHEN THE SUTURE WAS REMOVED, THE WOUND AGAIN OPENED FROM THE DERMIS. THERE WAS NO INFECTION SYMPTOM, AND WHEN THE SURGEON LOOKED INSIDE, THE TISSUE AROUND SPL HAD DISAPPEARED, AND THE WOUND HAD OPENED DUE TO IT. THEREFORE, THE SPL WAS REMOVED AND SUBCUTANEOUS SUTURE WAS PERFORMED WITH VCP NODE. HOSPITALIZATION WAS PROLONGED FOR ABOUT 1 WEEK, AND ADDITIONAL TREATMENTS WERE PERFORMED IN A TREATMENT ROOM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL A FEW DAYS AGO AND IS NOW UNDER OBSERVATION. IT WAS REPORTED THAT THE SURGEON RECENTLY CHANGED A HORIZONTAL MATTRESS SUTURE TO A HEART-SHAPED SUTURE BECAUSE THE SURGEON THOUGHT IT MIGHT BE BAD TO PUT THE SUTURE CLOSE TO THE EPIDERMIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 15942688 ↗