STRATAFIX SXPP1A433Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031245143), received between Mar 9, 2021 and Apr 27, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 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 SUTURES BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000117 ↗
• MalfunctionApr 27, 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 SUTURES BROKE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000115 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON AN UNKNOWN DATE BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN IN MYOMECTOMY CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768064 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT BARBED SUTURE WAS BREAKING- MULTIPLE IN SAME BOX/LOT. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS THERE. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316559 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT BARBED SUTURE WAS BREAKING- MULTIPLE IN SAME BOX/LOT. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS THERE. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316557 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT BARBED SUTURE WAS BREAKING- MULTIPLE IN SAME BOX/LOT. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS THERE. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316554 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT BARBED SUTURE WAS BREAKING- MULTIPLE IN SAME BOX/LOT. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES WAS THERE. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316553 ↗
• MalfunctionOct 6, 2025Break; Material Frayed; Material Separation; Break; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALE REP THAT THE SUTURE WAS FRAYING, BREAKING OFF, AND EVENTUALLY SPLIT, NO PATIENT HARM OR CONSEQUENCES WERE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221492 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS SHREDDED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349511 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE BEEN ADVISED BY OUR SUPPLIER (B)(4) TO CONTACT JOHNSON AND JOHNSON DIRECTLY REGARDING A FAULTY BOX OF SUTURES PURCHASE. THE SUTURES ARE ETHICON VICRYL 5/0 PS-3/8 16MM REVERSE CUTTING, 45CM. THE ISSUE: THE THREAD KEEPS DETACHING FROM THE NEEDLE EVERY TIME WE USE IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206492 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS ¿SKIING¿ THE NEEDLE TO REMOVE IT FROM A 8 MM TROCAR PORT. DURING THE PROCESS OF ¿SKIING¿ THE NEEDLE, THE NEEDLE SPLIT IN HALF. ONE DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205562 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP WHO WAS IN THE CASE THAT WHILE SUTURING THE SUTURE SPLIT BUT DID NOT DETACH FROM THE NEEDLE AT THE SWEDGE. THIS HAPPENED WITH TWO DIFFERENT SUTURE CODES DURING THE CASE. SAME SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. NO PRODUCT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134128 ↗
• MalfunctionMay 29, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP, SXPP1B410 THE TISSUE WAS SLIPPING AND NOT HOLDING WITH THE THICKER TISSUE. THE BARBED TISSUE WAS NOT HOLDING AS THE SURGEON THOUGHT THE BARBED SUTURE SHOULD. SXPP1A402 THERE WAS TO MUCH MEMORY IN THE EIGHTEEN INCH. SXPP1A433 THE SUTURE FRAYED AT THE JUNCTION BETWEEN THE NEEDLE AND THE START OF THE BARBS DUE TO MULTIPLE GRASPING WITH THE ROBOTIC GRASPER. CASE WAS COMPLETED WITH LIKE PRODUCTS. NO DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104913 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930280 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930279 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930278 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A MYOMECTOMY (B)(6) 2025 AND BARBED SUTURE WAS USED. WHEN THE DOCTOR WAS SUTURING AT THE END. THE SUTURE SPLIT. THE NEEDLE WAS KEPT AND THE PART OF THE SUTURE THAT SPLIT. CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741418 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR NOTICED THAT A FEW CENTIMETERS OF THE SUTURE CLOSE TO NEEDLE WAS BROKEN LIKE IT HAD A HOLE. THE DEFECTIVE PART OF THE SUTURE WAS FINALLY REMOVED, AND WAS NOT LEFT IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134792 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB SEPARATED AFTER FIRST BIT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696570 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STOMACH RESECTION IN 2022 AND A BARBED SUTURE WAS USED TO CLOSE THE FASCIA. SIX MONTHS POST-OP, IN 2023, AN INCISIONAL HERNIA WAS DISCOVERED. THE PATIENT UNDERWENT RE-OPERATION. THE SURGEON MENTIONED A RE-OP HAD NEVER HAPPENED BEFORE 2023. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 17870883 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STOMACH RESECTION IN 2022 AND A BARBED SUTURE WAS USED TO CLOSE THE FASCIA. SIX MONTHS POST-OP, IN 2023, AN INCISIONAL HERNIA WAS DISCOVERED. THE PATIENT UNDERWENT RE-OPERATION. THE SURGEON MENTIONED A RE-OP HAD NEVER HAPPENED BEFORE 2023. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 17870874 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD SEPARATED FROM THE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851427 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD SEPARATED FROM THE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851421 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD SEPARATED FROM THE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851419 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD SEPARATED FROM THE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851417 ↗