STRATAFIX SXMP1B409Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031236325), received between Nov 9, 2019 and Oct 31, 2025 — classified as 26 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (8 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436656 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OPERATION, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OPERATION, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436654 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436643 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436610 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436604 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436600 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436594 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436591 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436571 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436540 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OPERATION, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OPERATION, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436526 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OPERATION, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OPERATION, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23436518 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435761 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435750 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435749 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435723 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435717 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435716 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435713 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435712 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435702 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED HEALING GREATER THAN 2 MONTHS. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 23435697 ↗
• InjurySep 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22964847 ↗
• 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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22964845 ↗
• InjurySep 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 1 MONTH POST-OP, THE PATIENT EXPERIENCED A PARTIAL OR COMPLETE DISUNITY OF THE VAGINAL SCAR AND MAY HAVE REQUIRED A RESUMPTION OF SURGERY WITH A CHANGE OF LOT AND SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22964840 ↗