STRATAFIX SXPP1A401Recalls & reported problems

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 10705031219342), received between Nov 27, 2017 and Sep 30, 2026 — classified as 60 injuries, 386 malfunctions.

The most frequently reported specific device problem is “Break” (274 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 446 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. After the first stitch passes through Apex and the fixation tape is fixed, the tape pulls and breaks instantly. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947777 ↗
• MalfunctionSep 22, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861308 ↗
• MalfunctionSep 16, 2026Break

  It was reported that a patient underwent an Orthopedic procedure on an unknown date and barbed suture was used. The needle broke when sewing fibroid wounds . Changed another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789109 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757083 ↗
• MalfunctionSep 1, 2026Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548246 ↗
• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307951 ↗
• MalfunctionAug 18, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302008 ↗
• MalfunctionAug 18, 2026Product Quality Problem

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and barbed suture was used. During surgery, it was found that the tab was thin when the package was opened before use. Another package was opened but the tab was thin. This event was found before use. 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 50302001 ↗
• MalfunctionAug 5, 2026Break

  It was reported that a patient underwent a Total Knee Arthroplasty procedure on (b)(4) 2026 and barbed suture was used. During surgery, the suture was broken during use. The product was used on Joint capsule fascia. 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 50143388 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141639 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND USUTURE WAS USED. DURING SURGERY, THE PRODUCT WAS UNABLE TO LOCK THE SUTURE AT THE START DUE TO A BROKEN TAB. 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 25433920 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON USE SXPP1A401 , FIXATION TAP ISOLATE FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333143 ↗
• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216795 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING FASCIA, THE FIXATION TAP WAS DETACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074142 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON USE SXPP1A401. FIXATION TAP ISOLATE FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070045 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON USE SXX1A401 , NEEDLE ISOLATE FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035797 ↗
• MalfunctionApr 17, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT CEREBELLOPONTINE ANGLE TUMOR RESECTION SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DURING THE PREOPERATIVE EXAMINATION, IT WAS FOUND THAT THE OUTER PACKAGING OF THE SUTURE WAS DAMAGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913497 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN PLASTIC SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED 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 24680309 ↗
• MalfunctionMar 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN SURGEON WANT SUTURE WOUND , 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 24639252 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEMI OPEN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SEMI-OPEN SURGERY, WHEN THE DOCTOR USED STRATAFIX, BODY PART OF THE NEEDLE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 24626872 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE DURING SEWING AND IT TOOK AROUND 1 HOUR TO LOOK FOR THE NEEDLE. FINALLY, IT WAS RETRIEVED FROM THE PATIENT. AND THE OPERATION PROLONGED AROUND 2 HOURS. NOW THE PATIENT IS STABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24560886 ↗
• MalfunctionFeb 27, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN KNEE JOINT REPLACEMENT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER (HAIR) IMMEDIATELY ONCE OPENED THE PACKAGE WHEN PREPARING FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469170 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462020 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY FOR UTERINE LESIONS PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444842 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BODY PART OF THE NEEDLE WAS BROKEN DURING FASCIORRHAPHY. IT WAS NOT A CONTROL RELEASE NEEDLE. WHEN THE NEEDLE BROKE, A NEEDLE PIECE FELL INTO THE SURGICAL FIELD AND WAS IMMEDIATELY PICKED UP. MOST LIKELY, NO X-RAY OR CT WAS PERFORMED. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421391 ↗