STRATAFIX SXPP2B434Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031465152), received between Apr 23, 2024 and Apr 23, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 02-04-2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A CAESAREAN SECTION, THE DOCTOR FELT THAT THE BARB WAS MISSING. THE BARB MALFORMATION WAS SUSPECTED. THE PRODUCT WAS USED ON THE MYOMETRIUM. 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 24971084 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN AT THE BASE OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 24043527 ↗
• MalfunctionAug 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A CAESAREAN SECTION, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING SURGERY. 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 22838592 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT A DELIVERY THAT WAS STOPPED AND TRANSFERRED TO A C-SECTION ON (B)(6) 2024 AND CONTINUOUS BARBED SUTURE WAS USED. THE UTERUS WAS SOFTER THAN A NORMAL SCHEDULED C-SECTION, BUT IT IS NOT UNCOMMON. THE PROCEDURE WAS PERFORMED BY A FACILITY AND DOCTOR WHO WAS EXPERIENCED WITH THE PROCEDURE. THE PRODUCT WAS USED ON THE MYOMETRIUM. C-SECTION WAS COMPLETED AT 5PM. THERE WERE NO PROBLEMS WITH THE SUBSEQUENT PROCESS AFTER THE SURGERY AND THERE WERE NO PROBLEMS WITH VALUE. 6 HOURS LATER, THE PATIENT SUDDENLY CHANGED. THE PATIENT FACE TURNED PALE. THE HEMOGLOBIN LEVEL DECREASED. THE PATIENT WAS TRANSPORTED TO A DIFFERENT HOSPITAL IN AN EMERGENCY. THERE WAS STILL 3,000ML BLEEDING IN THE ABDOMINAL CAVITY DURING THE TRANSPORT. THE NEW HOSPITAL REPORTED THAT THE MYOMETRIUM WAS OPENED AND THAT A FINGER COULD FIT THROUGH IT. NOT THE SUTURE WAS BROKEN, THE TISSUE WAS TORN. THE DOCTOR CONFIRMED THAT THE SUTURE WAS PERFORMED PROPERLY BEFORE ABDOMINAL CLOSURE. THE DOCTOR SEEMED CONFUSED ABOUT WHAT CAUSED IT. THE NEXT DAY THE PATIENT HAD REOPENED DUE TO A HEMATOMA ON THE UTERUS BLADDER. THE SECOND TIME DID NOT SEEM TO BE RELATED TO THE SUTURE. THE D

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Wound Dehiscence

  MAUDE report 21082305 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE. THE SUTURE HAD BEEN DETACHED DURING USE FOR CONTINUOUS SUTURING, SO USE WAS TOPPED. 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 19164635 ↗