STRATAFIX SXPP1B422Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031235939), received between Nov 12, 2018 and May 1, 2026 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. AS PER CUSTOMER FEEDBACK, THERE WAS NO BARBS ON THE SUTURE LINE. THERE WAS A 10 MINUTE DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058655 ↗
• MalfunctionApr 2, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE BARBED SUTURE WAS USED. THE SUTURE DIDN'T LOCK THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769225 ↗
• MalfunctionMar 19, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON WAS USING BARBED SUTURE FOR ANASTOMOSIS DURING PROCTECTOMY CASE AND THE SUTURE SLIPPED AFTER APPLICATION AND BLEEDING STARTED. 3 MORE FOILS WERE USED BUT NONE OF THE FOILS HAD ANY BARBS TO HOLD THE TISSUE DURING APPROXIMATION. THERE WERE NO BARBS VISIBLE OR FELT DURING SURGERY. THERE WAS AN APPROX. 30 MINUTE SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638252 ↗
• MalfunctionMar 19, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON WAS USING BARBED SUTURE FOR ANASTOMOSIS DURING PROCTECTOMY CASE AND THE SUTURE SLIPPED AFTER APPLICATION AND BLEEDING STARTED. 3 MORE FOILS WERE USED BUT NONE OF THE FOILS HAD ANY BARBS TO HOLD THE TISSUE DURING APPROXIMATION. THERE WERE NO BARBS VISIBLE OR FELT DURING SURGERY. THERE WAS AN APPROX. 30 MINUTE SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638246 ↗
• MalfunctionMar 19, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON WAS USING BARBED SUTURE FOR ANASTOMOSIS DURING PROCTECTOMY CASE AND THE SUTURE SLIPPED AFTER APPLICATION AND BLEEDING STARTED. 3 MORE FOILS WERE USED BUT NONE OF THE FOILS HAD ANY BARBS TO HOLD THE TISSUE DURING APPROXIMATION. THERE WERE NO BARBS VISIBLE OR FELT DURING SURGERY. THERE WAS AN APPROX. 30 MINUTE SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638245 ↗
• MalfunctionMar 19, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SURGEON WAS USING BARBED SUTURE FOR ANASTOMOSIS DURING PROCTECTOMY CASE AND THE SUTURE SLIPPED AFTER APPLICATION AND BLEEDING STARTED. 3 MORE FOILS WERE USED BUT NONE OF THE FOILS HAD ANY BARBS TO HOLD THE TISSUE DURING APPROXIMATION. THERE WERE NO BARBS VISIBLE OR FELT DURING SURGERY. THERE WAS AN APPROX. 30 MINUTE SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638241 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING THORACIC SURGERY, AT THE SWAGE PART OF THE NEEDLE WAS BROKEN, BUT THE BROKEN NEEDLE DID NOT REMAIN IN THE BODY AND WAS ALREADY RETRIEVED. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. 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 23783042 ↗
• MalfunctionAug 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SUTURING, THE NEEDLE DETACHED FROM THE SUTURE REMAINING INSIDE THE MUCOSA AND THIS MADE THE PROCEDURE PARTICULARLY COMPLEX FOR THE REMOVAL. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851800 ↗
• MalfunctionApr 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PARTIAL NEPHRECTOMY, THE SUTURE WAS NOT CINCHING DOWN. WHEN THEY DID A PASS, THEY WERE NOT ABLE TO CINCH DOWN. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860169 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING MULTIPLE PARTIAL NEPHRECTOMY 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. NO FURTHER INFORMATION WAS PROVIDED TO THE REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560850 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING MULTIPLE PARTIAL NEPHRECTOMY 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. NO FURTHER INFORMATION WAS PROVIDED TO THE REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560841 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING MULTIPLE PARTIAL NEPHRECTOMY 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. NO FURTHER INFORMATION WAS PROVIDED TO THE REP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560825 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MALIGNANT PROSTATE TUMOR SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20581903 ↗
• MalfunctionOct 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROUX-EN-Y PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING A SLEEVE CONVERSION TO A ROUX-EN-Y PROCEDURE, DOCTOR WAS ABLE TO USE ABOUT FOUR INCHES OF THE SIX-INCH SUTURE BEFORE THE SUTURE BROKE OFF FROM NEEDLE. LOOKS LIKE IT COULD HAVE ALSO PULLED THROUGH A BIT, THERE IS STILL A PIECE OF THREAD WITH THE NEEDLE. SALES REP GRABBED ANOTHER SUTURE TO FINISH THE SUTURE LINE. DELAYED ABOUT A MINUTE, BUT CASE WAS COMPLETED. NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385644 ↗
• MalfunctionAug 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055971 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19932894 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY PROCEDURE ON (B)(6) 2024, AND SUTURE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREE SUTURES BROKE WHILE SUTURING. ONE STRATAFIX DURING THE URETHROVESICLE ANASTOMOSIS, ONE MONOCRYL DURING THE OVER SEW OF THE CONNECTION BETWEEN THE URETHRA AND THE BLADDER, AND A DYED MONOCRYL WHILE SUTURING THE OTHER SIDE OF THE ANASTOMOSIS OVER SEW BETWEEN THE URETHRA AND THE BLADDER. FOR EACH, ANOTHER SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. LEAK TEST WAS PREFORMED AND NO LEAKS WERE FOUND. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER REPORTED ISSUES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838626 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT CERVICAL LYMPH NODE BIOPSY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, AT THE TIME OF WOUND CLOSURE, THE PRODUCT WAS USED ON CERVICAL DERMIS WITH CONTINUOUS SUTURE. THE SUTURE ADHESIVE PORTION OF THE LOOP WAS PARTIALLY DETACHED, AND THE SUTURE WAS POPPING OUT WHEN THE 1ST STITCH WAS SUTURED. THE SEVERED SUTURE WAS REMOVED FROM THE BODY AND A NEW SUTURE WAS USED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18357639 ↗
• MalfunctionJul 13, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON NOTICED THE SXPP1B422 IT WASN'T CATCHING TISSUE GOOD WITH THE BARB WIRES LIKE THEY USUALLY DO DURING AN UNKNOWN PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317588 ↗
• MalfunctionDec 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LAPAROSCOPIC PROSTATECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS USED FOR VESICOURETHRAL ANASTOMOSIS, BUT THE PRODUCT WAS STOPPED USING BECAUSE THERE WERE TOO MANY LEAKS. THE HOSPITAL ORIGINALLY USED V-LOC AND SWITCHED TO STRATAFIX AROUND JULY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977466 ↗
• MalfunctionDec 1, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY ON (B)(6) 2022 AND THE BARBED SUTURE WAS USED. IT WAS REPORTED THE PRODUCT WAS USED FOR VESICOURETHRAL ANASTOMOSIS, THE PRODUCT WAS STOPPED USING BECAUSE OF TOO MANY LEAKS. THE HOSPITAL ORIGINALLY USED V-LOC AND SWITCHED TO STRATAFIX AROUND JULY. IT MAY HAVE BECOME LOOSE BECAUSE THE BARB WAS SHALLOW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896833 ↗
• InjuryApr 19, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE WAS BROKEN COMPLETELY WITH A SUTURE THAT REOPENED ON D+2 (SMALL HAIL SUTURE AT THE FOOT OF THE BYPASS LOOP). THERE WAS A COMPLETE SUTURE RELEASE. THIS LED TO A SURGICAL RECOVERY REQUIRED (BY LAPAROTOMY) AND A HOSPITAL STAY OF 1 WEEK MINIMUM (THE PATIENT IS STILL IN THE HOSPITAL). AN ANTIBIOTHERAPY HAD TO BE IMPLEMENTED FOR SEVERE SEPSIS ASSOCIATED WITH THIS RELEASE. IT WAS ALSO REPORTED THAT THE SURGEON NOTICED THAT FOR A FEW WEEKS THE BARBED SUTURES APPEARED TO FRAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Sepsis

  MAUDE report 14141248 ↗
• InjuryFeb 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THERE WAS A LOSS OF SUTURE NEEDLE IN THE TISSUES DURING RECONSTRUCTION OF A VESICOURETHRAL ANASTOMOSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13536418 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404737 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821194 ↗