STRATAFIX SXMP1B410Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031236448), received between Feb 25, 2019 and Oct 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS USING THE PRODUCT, HE AID THAT THE BARBE ON THE SUTURE WAS NOT OBVIOUS LIKE THE OTHERS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437567 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON WAS CLOSING THE SUBCUTICULAR LAYER OF THE SKIN AND THE SUTURE SHE WAS USING SNAPPED. SHE SAID IT HAD NEVER HAPPENED BEFORE AND OPENED A NEW SUTURE TO FINISH CLOSING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075489 ↗
• MalfunctionApr 14, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. ON (B)(6) 2023, WHEN VISITING AN OUTPATIENT CLINIC AFTER SURGERY, THE PATIENT FEELS PAIN AND DISCOMFORT DUE TO DISCOMFORT IN THE SURGICAL AREA. INFLAMMATION WAS ALSO EXPERIENCED. SOME PARTS OF THE SUTURE WERE NOT ABSORBED AND REMOVED. 70 DAYS HAVE PASSED SINCE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation; Pain

  MAUDE report 16742460 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION KNEE REPLACEMENT SURGERY ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE CUT IN HALF. THE SURGERY WAS DELAYED DUE TO THIS REPORTED EVENT BY FIVE MINUTES. THE PATIENT WAS SUTURED AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675803 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION KNEE REPLACEMENT SURGERY ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE CUT IN HALF. THE SURGERY WAS DELAYED DUE TO THIS REPORTED EVENT BY FIVE MINUTES. THE PATIENT WAS SUTURED AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675799 ↗
• MalfunctionFeb 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE SEWEGE WHILE THE SURGEON WAS CLOSING THE PARATANIUM. THE SUTURE DID SEPARATE COMPLETELY FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367670 ↗
• MalfunctionFeb 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE AT THE SEWEGE WHILE THE SURGEON WAS CLOSING THE PARATANIUM. THE SUTURE DID SEPARATE COMPLETELY FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367669 ↗