STRATAFIX SXPP1A405Recalls & reported problems

Summary

The FDA's MAUDE database contains 617 adverse event reports that list this exact device (DI 10705031227682), received between Dec 7, 2017 and Sep 30, 2026 — classified as 32 injuries, 585 malfunctions.

The most frequently reported specific device problem is “Break” (438 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 617 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950946 ↗
• MalfunctionSep 25, 2026Material Separation

  It was reported that a patient underwent an unspecified procedure on (b)(6)2026 and barbed suture was used. At 13:05, when using suture to suture the uterus, the problem of pulling off suture needle happened. The product has been replaced. There were no adverse patient consequences. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900304 ↗
• MalfunctionSep 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889742 ↗
• MalfunctionSep 21, 2026Delivered as Unsterile Product

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. It was reported that the primary package of the suture was found damaged prior to use. 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 50840774 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542769 ↗
• InjuryAug 18, 2026Break

  It was reported that a patient underwent a single port laparoscopic abdominal myomectomy, pelvic adhesiolysis, and diagnostic curettage under general anesthesia on (b)(6) 2026 and a barbed suture was used. Clinical diagnosis: 1. (Multiple) uterine leiomyoma (type V) 2. Female pelvic adhesions. 3. Abnormal uterine bleeding 4, (left adnexal area cystic mass) ovarian cyst 5, moderate anemiaDuring the procedure, the surgeon used suture to stop bleeding on the uterine wound. Operate was normal according to surgical specifications. During use, the needle that came with the suture suddenly broke and fell into the abdominal cavity. Due to the needle remaining in the abdominal cavity, additional surgical exploration procedures were required, which prolonged the surgical duration and increased the risk of abdominal exposure, tissue damage, and infection. After the doctor discovered the broken needle, immediate measures were taken: abdominal exploration was performed immediately during the operation. Due to severe pelvic adhesion in the patient, it was difficult to find it under laparoscopy, so the surgery was converted to open surgery. After careful search, the broken needle was successfully

  Patient problems: Foreign Body In Patient

  MAUDE report 50306651 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305979 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142382 ↗
• MalfunctionJul 29, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070366 ↗
• MalfunctionJul 29, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067866 ↗
• MalfunctionJun 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6), 2026, AND BARBED SUTURE WAS USED. AROUND 13:00, THE DOCTOR FINISHED SUTURING THE UTERUS DURING SURGERY. DURING THE PROCESS OF RINSING AND EXAMINING THE WOUND, IT WAS FOUND THAT THE SUTURE WAS BROKEN AND THERE WAS BLEEDING FROM THE WOUND. IN ORDER TO PREVENT FURTHER BLEEDING FROM THE WOUND AND ENSURE THE SUTURING EFFECT, THE DOCTOR REPLACED SIMILAR PRODUCTS FOR SUTURING. THIS ACCIDENT DID NOT CAUSE SUBSTANTIAL HARM TO THE PATIENT, BUT IT AFFECTED THE SMOOTH PROGRESS OF THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595030 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON 27-MAY-2026 AND BARBED SUTURE WAS USED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25583768 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN; APAROSCOPIC EXTENSIVE HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY (SXMP1B452/109AGU. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY (SXPP1A405/10ABD4, AND THE FIXATION FEATURE WAS FOUND DETACHED DURING SURGERY. BESIDES, THE SUTURE BROKE. CHANGED TO 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 25151183 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY BY APPOINTMENT FOR UTERINE FIBROIDS. AFTER THE PEELING WAS COMPLETED, THE UTERINE WOUND WAS SUTURED. WHEN USING THE SUTURE, THE SUTURE BROKE AND WAS IMMEDIATELY REPLACED. THE SUTURE STATUS WAS REPEATEDLY CONFIRMED, AND THERE WAS NO ABNORMAL BLEEDING. THE PATIENT RECOVERED WELL AFTER SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020635 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6), 2026 AND BARBED SUTURE WAS USED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953249 ↗
• InjuryApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HAND-ASSISTED NEPHRECTOMY ON AN UNKNOWN DATE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE BROKE IN THE MIDDLE ON THE PATIENT. AS A RESULT, THE PATIENT EXPERIENCED A WOUND DEHISCENCE COMPLICATION. THE PATIENT IS CURRENTLY UNDERGOING A PROCEDURE TO REPAIR THE DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abdominal Pain; Wound Dehiscence

  MAUDE report 24897217 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE FIXATION FEATURE DETACHED FROM THE SUTURE DURING THE 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 24889180 ↗
• MalfunctionApr 13, 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 24865441 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6), 2026 AND BARBED SUTURE WAS USED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829881 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. AFTER THE REMOVAL OF UTERINE FIBROIDS, DOCTOR USED SUTURE TO SUTURE THE PATIENT'S UTERUS. AFTER SUTURING, THE DOCTOR PULLED OUT THE SUTURE, WHICH BROKE. UPON DISCOVERING THIS SITUATION, MEDICAL STAFF PROMPTLY REPLACED THE SUTURE WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780646 ↗
• MalfunctionApr 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC UTERINE FIBROID SURGERY ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, SEPARATION OF THE SUTURE AND NEEDLE OCCURRED UPON SUTURING OF THE UTERUS. ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE SUTURING AND COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774618 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTHROPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO 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 24675766 ↗
• MalfunctionMar 6, 2026Material Separation; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO PLANNED USE. BESIDES, UPON OPENING THE PACKAGING FOR INSPECTION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533135 ↗
• MalfunctionMar 6, 2026Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON(B)(6) 2026 AND BARBED SUTURE WAS USED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530307 ↗
• MalfunctionMar 5, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. THE NEEDLE DID NOT FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521442 ↗