STRATAFIX SXPP2B431Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031464735), received between Sep 25, 2023 and Sep 15, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779237 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778912 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778897 ↗
• MalfunctionSep 15, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778704 ↗
• MalfunctionSep 15, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778675 ↗
• InjuryApr 1, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A URINE LEAK. THE PATIENT HAD AN IR PLACE A DRAIN ON SUNDAY (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Obstruction/Occlusion; Pain

  MAUDE report 21744625 ↗
• MalfunctionMar 10, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING MULTIPLE PROSTATECTOMY PROCEDURES THAT EITHER THE NEEDLE WOULD POPPED OFF THE SUTURE OR THE SUTURE WOULD BREAK. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560350 ↗
• MalfunctionMar 10, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING MULTIPLE PROSTATECTOMY PROCEDURES THAT EITHER THE NEEDLE WOULD POPPED OFF THE SUTURE OR THE SUTURE WOULD BREAK. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560319 ↗
• MalfunctionFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, BEFORE SUTURING, WHEN IT WAS TRIED TO START SUTURING BY HOLDING WITH THE ROBOTIC ARM, THE NEEDLE AND SUTURE WERE DETACHED LIKE A CONTROL RELEASE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER LIKE DEVICE WAS USED, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317861 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY: RALP ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR VESICOURETHRAL ANASTOMOSIS. THE SUTURE METHOD WAS CONTINUOUS SUTURE. POST-OP, AT A FOLLOW-UP VISIT, THE PATIENT'S URINE OUTPUT WAS POOR, SO THE INSIDE OF THE URETHRA WAS INSPECTED WITH A SCOPE, AND A NEOINTIMA HAD DEVELOPED AROUND THE BARBED SUTURE WHERE IT HAD BEEN USED FOR VESICOURETHRAL ANASTOMOSIS, WHICH WAS LIKE A LID OVER THE URETHRA. THE NEOINTIMA WAS PATHOLOGICALLY AN INFLAMMATORY GRANULOMA. THE NEW ENDOMETRIUM WAS SCRAPED OFF, BUT THE NEW ENDOMETRIUM APPEARED AGAIN IN THE SAME AREA, SO THE SURGEON SUGGESTED THAT THE SUTURE MATERIAL MIGHT HAVE BEEN THE CAUSE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ATTENDS THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Inflammation; Insufficient Information; Pain

  MAUDE report 18657846 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LAPAROSCOPIC PROSTATECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE ON BLADDER. ANOTHER PRODUCT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809030 ↗