STRATAFIX SXPP1B407Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10705031236103), received between May 1, 2018 and Sep 18, 2026 — classified as 14 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828279 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50235327 ↗
• MalfunctionApr 23, 2026Material Separation

  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 DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971186 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING C-SECTION, THE NEEDLE DETACHED IN THE MIDDLE OF UTERUS SUTURING. THE PRODUCT WAS USED ON THE UTERUS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618439 ↗
• MalfunctionMar 17, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A CAESAREAN SECTION, THE DOCTOR REPORTED THAT THE BARB GRIP WAS WEAK. THE PRODUCT WAS USED ON THE MYOMETRIUM. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617833 ↗
• MalfunctionFeb 2, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING C-SECTION, THIS PRODUCT WAS USED FOR UTERINE MYOMETRIAL SUTURING. THE BARBS FELT WEAKER THAN USUAL, WHICH CAUSED CONCERN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237069 ↗
• MalfunctionDec 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, WHEN OPENED THE PACKAGE, THE SUTURE AND NEEDLE WERE ALREADY DETACHED, SO THE PRODUCT COULD NOT BE USED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772459 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED DURING USE. IT OCCURRED 2 PRODUCTS IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647515 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED DURING USE. IT OCCURRED 2 PRODUCTS IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647514 ↗
• MalfunctionOct 31, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A CAESAREAN SECTION, IT WAS FOUND WHEN THE PACKAGE WAS OPENED THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. THIS EVENT WAS FOUND BEFORE USE. 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 23436887 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A CAESAREAN SECTION (C-SECTION), WHEN USING THE PRODUCT ON THE MYOMETRIUM, THE SUTURE WAS BROKEN ABOUT THE FIRST 2ND STITCH. IT IS UNKNOWN WHERE IT BROKE. THE NEEDLE-SUTURE HAS ALREADY BEEN DISCARDED, SO IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER. THE KIT (ICKIT29) WAS REGISTERED WITH JJKK AND QA. THIS IS ONE OF SXPP1B407 INCLUDED IN ICKIT29. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394135 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2025 AND A BARBED SUTURE WAS USED FOR 2 LAYER SUTURE ON THE MYOMETRIUM. POST-OP. AN ABSCESS WAS FOUND ON THE SUTURING SITE OF THE MYOMETRIUM A FEW DAYS LATER AFTER SURGERY. REOPERATION AND DRAINAGE WERE PERFORMED. THE PATIENT WAS STABLE AFTER THE REOPERATION. THE DOCTOR COMMENTED THAT THE PATIENT HAD RUPTURED WATER AND WAS AT RISK OF INTRAUTERINE INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 22965359 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION FOR PREGNANCY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE DOCTOR SAID THERE WAS A PROBLEM WITH HIS NEEDLE TECHNIQUE. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN SUTURING THE SECOND LAYER OF THE MYOMETRIUM. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE SECOND LAYER OF THE MYOMETRIUM. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702259 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN OPEN SURGERY, THE SUTURE WAS BROKEN DURING USE. 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663457 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION IN (B)(6) 2025 AND BARBED SUTURE WAS USED FOR TWO-LAYER SUTURE. THE PART OF THE UTERUS AWAY FROM THE SUTURES HAD TORN. THE PATIENT WAS URGENTLY TRANSPORTED AND ADDITIONAL TREATMENT WAS PERFORMED USING A DIFFERENT TYPE OF SUTURE. THE DOCTOR COMMENTED THAT MAYBE THERE IS A POSSIBILITY THAT OTHER PARTS OF THE UTERUS WAS APPLIED TENSION BECAUSE THE BARBED SUTURE IS RESISTANT TO TENSION. THE PATIENT'S UTERUS IS THIN. IN THIS CASE, THE BARBED SUTURE MAY NOT BE SUITABLE BECAUSE ADDITIONAL TENSION IS APPLIED WHEN USING A BALLOON TO HEMOSTASIS. THE PATIENT RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Laceration(s); Unspecified Tissue Injury

  MAUDE report 22628339 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A CAESAREAN SECTION (C-SECTION), THE SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS USED ON THE MYOMETRIUM. 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 21663436 ↗
• MalfunctionMar 12, 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, THE NEEDLE WAS BROKEN AT THE MIDDLE PART DURING SUTURING. 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 21590193 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143957 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143956 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143954 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143952 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143947 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143944 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143943 ↗
• MalfunctionJan 13, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE STERILIZATION PACKAGE WAS BROKEN WHEN THE PRODUCT WAS CHECKED. THIS PRODUCT WAS DISCARDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143941 ↗