STRATAFIX SXMP2B402Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031464421), received between Oct 3, 2023 and Sep 29, 2026 — classified as 21 injuries, 9 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K192580); they may or may not involve this specific model.

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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. During suturing procedure needle disconnected from the suture. The small needle was very difficult to find in the abdominal cavity, which posed a direct threat to the operated patient. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: Foreign Body In Patient

  MAUDE report 50936694 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50936642 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936582 ↗
• MalfunctionSep 1, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549102 ↗
• InjuryMar 10, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED RADICAL PROSTATECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR URETERAL ANASTOMOSIS. THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK. THE PATIENT EXPERIENCED MACROHEMATURIA, PAIN IN THE LOWER ABDOMEN AND PAIN WHEN URINATING. NO FURTHER SURGICAL INTERVENTION WAS NECESSARY, AS THERE WAS NO COMPLETE SUTURE FAILURE. THE CATHETER HAD TO REMAIN IN PLACE LONGER TO ALLOW THE ANASTOMOSIS TO HEAL COMPLETELY, WHICH EXTENDED THE PATIENT'S HOSPITAL STAY. THE SUTURE BARBS DID NOT STAY ENGAGED IN THE TISSUE POST OPERATIVELY. THE SURGEON HAS RULED OUT ROBOT-ASSOCIATED COMPLICATIONS AS THERE WERE NO CHANGES IN GRIP FORCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Hematuria; Incontinence; Pain

  MAUDE report 24560704 ↗
• InjuryMar 10, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED RADICAL PROSTATECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR URETERAL ANASTOMOSIS. THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK. THE PATIENT EXPERIENCED MACROHEMATURIA, PAIN IN THE LOWER ABDOMEN AND PAIN WHEN URINATING. NO FURTHER SURGICAL INTERVENTION WAS NECESSARY, AS THERE WAS NO COMPLETE SUTURE FAILURE. THE CATHETER HAD TO REMAIN IN PLACE LONGER TO ALLOW THE ANASTOMOSIS TO HEAL COMPLETELY, WHICH EXTENDED THE PATIENT'S HOSPITAL STAY. THE SUTURE BARBS DID NOT STAY ENGAGED IN THE TISSUE POST OPERATIVELY. THE SURGEON HAS RULED OUT ROBOT-ASSOCIATED COMPLICATIONS AS THERE WERE NO CHANGES IN GRIP FORCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Hematuria; Incontinence; Pain

  MAUDE report 24560699 ↗
• MalfunctionOct 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE POPPED OFF THE SUTURE AND WAS RETAINED IN THE BODY. RETRIEVED BY SURGEON AND CONFIRMED BY X-RAY, SURGEON, AND RADIOLOGIST. THE PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392701 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WIRE IS STABBING STRATAFIX3.0 IS NOT BEING EFFECTIVE IN THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912342 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE WIRE IS "CRUMBLING", NOT BEING EFFECTIVE IN THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897213 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED WHICH CAUSED STRICTURES AND ANASTOMOTIC LEAKS. NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED.

  Patient problems: Failure to Anastomose; Obstruction/Occlusion

  MAUDE report 22836116 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED WHICH CAUSED STRICTURES AND ANASTOMOTIC LEAKS. NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED.

  Patient problems: Failure to Anastomose; Obstruction/Occlusion

  MAUDE report 22836115 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RALP PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED BLADDER NECK ANASTOMOSIS LEAKING. THE SAME TECHNIQUE HAS BEEN USED WITH THIS NEW SUTURE COMPARED TO A DIFFERENT ONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Hematuria

  MAUDE report 22435655 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED BLADDER NECK ANASTOMOSIS LEAKING. THE SAME TECHNIQUE HAS BEEN USED WITH THIS NEW SUTURE COMPARED TO A DIFFERENT ONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Hematuria

  MAUDE report 22311019 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196784 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196782 ↗
• InjuryMay 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLADDER PROCEDURE ON AN UNKNOWN DATE OVER THE LAST 6 MONTHS AND SUTURE WAS USED. THE PATIENT EXPERIENCED A LEAKING ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 22080608 ↗
• InjuryMay 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLADDER PROCEDURE ON AN UNKNOWN DATE OVER THE LAST 6 MONTHS AND SUTURE WAS USED. THE PATIENT EXPERIENCED A LEAKING ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 22080486 ↗
• InjuryMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLADDER PROCEDURE ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. PATIENT EXPERIENCED BLADDER NECK LEAKAGE FROM THE ANASTOMOSIS. SUTURE IS DISSOLVING IN 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21730802 ↗
• InjuryMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLADDER PROCEDURE ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. PATIENT EXPERIENCED BLADDER NECK LEAKAGE FROM THE ANASTOMOSIS. SUTURE IS DISSOLVING IN 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21730801 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR POSTERIOR RECONSTRUCTION WITH ROCCO STITCH. THE PATIENT EXPERIENCED A LEAK FROM ANASTAMOSIS AT APPROX 2-3 WEEKS POST SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21661977 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR POSTERIOR RECONSTRUCTION WITH ROCCO STITCH. THE PATIENT EXPERIENCED A LEAK FROM ANASTAMOSIS AT APPROX 2-3 WEEKS POST SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21661975 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WS USED FOR ANASTOMOSIS. THE PATIENT HAD LEAKAGE AT ANASTOMOSIS. THE SURGEON MAY HAVE INSERTED A DRAIN IN THIS PATIENT. THE SURGEON SAYS LEAKAGE HAS CAUSED INFECTION AND 6 WEEK HOSPITAL STAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 20749915 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WS USED FOR ANASTOMOSIS. THE PATIENT HAD LEAKAGE AT ANASTOMOSIS. THE SURGEON MAY HAVE INSERTED A DRAIN IN THIS PATIENT. THE SURGEON SAYS LEAKAGE HAS CAUSED INFECTION AND 6 WEEK HOSPITAL STAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 20749903 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WS USED FOR ANASTOMOSIS. THE PATIENT HAD LEAKAGE AT ANASTOMOSIS. THE SURGEON MAY HAVE INSERTED A DRAIN IN THIS PATIENT. THE SURGEON SAYS LEAKAGE HAS CAUSED INFECTION AND 6 WEEK HOSPITAL STAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 20749877 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WS USED FOR ANASTOMOSIS. THE PATIENT HAD LEAKAGE AT ANASTOMOSIS. THE SURGEON MAY HAVE INSERTED A DRAIN IN THIS PATIENT. THE SURGEON SAYS LEAKAGE HAS CAUSED INFECTION AND 6 WEEK HOSPITAL STAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 20749864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192580. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2024 · Mar 8, 2024 · Open, Classified
  STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft