STRATAFIX SXPP1A408Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031219335), received between Jan 30, 2018 and Sep 17, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FIXATION TAP ISOLATE FROM SUTURE. IT SEPARATED WHEN PULLING THE SUTURE THREAD AT FIRST STITCHING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073426 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FIXATION TAP ISOLATE FROM SUTURE. IT SEPARATED WHEN PULLING THE SUTURE THREAD AT FIRST STITCHING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073371 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE FIXATION TAP ISOLATE FROM SUTURE DURING OPERATION/SUTURING (DURING HANDLING OF SUTURE ON THE PATIENT). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896971 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND BARBED SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN WHEN ONLY SUTURING WAS PERFORMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819333 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND BARBED SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN WHEN ONLY SUTURING WAS PERFORMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819240 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THE SURGEON WAS CLOSING THE SUBCUTANEOUS WOUND, THE SUTURE BROKE APART IN A MELTED-LIKE MANNER, EVEN THOUGH THERE WAS NO EXCESSIVE TENSION OR PULLING APPLIED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22558473 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED WHEN SURGEON USED SUTURE, FIXATION TAP ISOLATE FROM SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863761 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE OR PRIOR USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS UNABLE TO USE DUE TO MISSING END SQUARE OF THE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596262 ↗
• MalfunctionMay 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871711 ↗
• MalfunctionJul 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SPINAL PROCEDURE ON (B)(6) 2020 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE AT THE 1ST OR THE 2ND STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250610 ↗
• MalfunctionMar 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING FOR FASCIA CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456292 ↗
• MalfunctionDec 3, 2018Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2018 AND BARBED SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PULLING THE SUTURE AFTER FIRST PASSING BY CONTINUOUS SUTURING, AND THE FIXATION TAB WAS ALSO BROKEN. THE LOT NUMBER IS UNKNOWN. FURTHER DETAILS ARE NOT PROVIDED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125574 ↗
• MalfunctionJul 11, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679547 ↗
• MalfunctionApr 23, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2018 AND BARBED SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE WHILE CLOSING THE FASCIA USING CONTINUOUS SUTURING. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451400 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CHEST/ THORACIC PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. THE SURGEON¿S WAY OF SUTURING WAS AS USUAL. THE SUTURE IN QUESTION WAS INTENTIONALLY CUT TO BE RELEASED FROM THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440327 ↗
• MalfunctionJan 30, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. AFTER PLACING A FEW STITCHES ON THE TISSUE, THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7229904 ↗