STRATAFIX SXPP1A446Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031245112), received between Jan 10, 2019 and May 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT IN GYN ONCOLOGY HAD A BARBED SUTURE DETACH AT THE WEDGE. HE WAS PERFORMING A ROBOTIC HYSTERECTOMY AND ABOUT TO CLOSE THE CUFF WHEN IT SEPARATED. THIS SWEDGED NEEDLE POPPED OFF WHILE I WAS RELOADING IT UNDER NO PRESSURE. FIRST TIME THAT HAPPEN WITH THIS SUTURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ONE DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163821 ↗
• MalfunctionApr 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON(B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASE, CT2 NEEDLE POPPED OFF BARBED SUTURE WHEN TECH WAS REMOVING THROUGH THE TROCAR. NEEDLE FELL BACK INTO PATIENT ABDOMINAL CAVITY AND WAS LOST. SURGEON SAYS HE SEARCHED FOR ABOUT 10 MINUTES BEFORE THEY CALLED IN FOR XRAY. THEY WERE ABLE TO LOCATE THE NEEDLE AND REMOVE FROM PATIENT. THE TECH FEELS THE SWAGE WAS NOT SECURE ENOUGH, AS HE SAID IT HAPPENED ONCE BEFORE LAST WEEK. 2 LOT #S PROVIDED, UNSURE OF WHICH ONE WAS USED. PROCEDURE WAS DELAYED BY 10 MINUTES. NO ADVERSE EFFECT TO THE PATIENT. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829169 ↗
• MalfunctionApr 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING ROBOTIC HERNIA CASE, CT2 NEEDLE POPPED OFF BARBED SUTURE WHEN TECH WAS REMOVING THROUGH THE TROCAR. NEEDLE FELL BACK INTO PATIENT ABDOMINAL CAVITY AND WAS LOST. SURGEON SAYS HE SEARCHED FOR ABOUT 10 MINUTES BEFORE THEY CALLED IN FOR XRAY. THEY WERE ABLE TO LOCATE THE NEEDLE AND REMOVE FROM PATIENT. THE TECH FEELS THE SWAGE WAS NOT SECURE ENOUGH, AS HE SAID IT HAPPENED ONCE BEFORE LAST WEEK. 2 LOT #S PROVIDED, UNSURE OF WHICH ONE WAS USED. PROCEDURE WAS DELAYED BY 10 MINUTES. NO ADVERSE EFFECT TO THE PATIENT. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829165 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS PUTTING EXCESSIVE FORCE ON THE SUTURE TO APPROXIMATE THE INCISION. WHEN PULLING BY THE NEEDLE, IT POPPED THE NEEDLE FROM THE SUTURE. SURGEON ADVISED THAT IT WAS NOT A PRODUCT MALFUNCTION BUT USER ERROR. SURGEON TERMINATED THE STITCH AND USED A NEW SUTURE TO OVERLAP WHERE THE SUTURE BROKE TO HELP LOCK THE TERMINATED STITCH AND TAKE TENSION FROM HIGH STRESS POINTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780434 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE BARBED SUTURE ON HERNIATED STOMA DEFECT CLOSURE. ROBOTIC PROCEDURE. FELLOW WAS ON 3RD/4TH PASS AS NEEDLE DETACHED. THE PROCEDURE WAS DELAYED BY FIVE TO TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417469 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847040 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847038 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847024 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846575 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846566 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT 6 OF THE SUTURES KEPT SNAPPING IN A HERNIA CASE. SURGEON OPTED TO USE A V-LOCK TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846536 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HERNIA REPAIR ON (B)(6)2024 AND BARBED SUTURE WAS USED. DURING PROCEDURE, THE SUTURE SNAPPED WHILE CLOSING THE FACIA. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. EVENT SAMPLE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463260 ↗
• MalfunctionNov 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ROBOTIC SLEEVE PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THE NEEDLE POPPED OFF AT THE WEDGE AREA WHERE SUTURE IS CONNECTED TO THE NEEDLE DURING ROBOTIC SLEEVE PROCEDURE. WHEN PULLED THROUGH SUTURE, NEEDLE DETACHED WHILE INSERTING BEHIND SPLEEN AND HAD TO RETRIEVE AFTER X-RAY. NO PATIENT HARM BUT THERE WAS A 20¿30-MINUTE DELAY DUE TO THE X-RAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107576 ↗
• MalfunctionNov 8, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA REPAIR ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH A LIKE SUTURE FROM A DIFFERENT LOT WITH NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297770 ↗
• MalfunctionNov 8, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA REPAIR ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH A LIKE SUTURE FROM A DIFFERENT LOT WITH NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297746 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING REVERSE STITCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8232767 ↗