STRATAFIX SXMP1B119Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705031236745), received between Jan 2, 2019 and Sep 18, 2026 — classified as 9 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820906 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820758 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820751 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820745 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820738 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820576 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820477 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820424 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820418 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on an unknown date and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820396 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on (b)(6) 2026 and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820261 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on (b)(6)2026 and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820243 ↗
• MalfunctionSep 18, 2026Break

  It was reported that a patient underwent a Skin Closure procedure on (b)(6)2026 and barbed suture was used. During the procedure this barbed suture code has been breaking as they close the skin. They have been closing with this suture for a long time and never had issues. No delay or patient harm was reported. They noticed that it has been the last couple of cases that they have used the product on. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820140 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820081 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820055 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a knee surgery on an unknown date and barbed suture was used. The patient encountered pus collection. Additional information was requested.

  Patient problems: Purulent Discharge

  MAUDE report 50009368 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a hand surgery on an unknown date and barbed suture was used. The patient encountered pus collection and was treated with I&D. Additional information was requested.

  Patient problems: Purulent Discharge

  MAUDE report 50009367 ↗
• MalfunctionMay 12, 2026Device Markings/Labelling Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE PACKAGES DO NOT LOOK THE SAME. THEY'RE MISSING INFORMATION AND THE CUSTOMER IS WONDERING WHY SOME SYMBOLS ARE NOT ON THE OUTER AND INNER PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148527 ↗
• MalfunctionMay 7, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CLIENT REPORTS AN OBSERVATION RELATED TO STRATAFIX¿ 4-0 SUTURE ETHICON BRAND, CORRESPONDING TO THE FOLLOWING LOTS: (B)(4) UNITS LOT: 106BG7 AND (B)(4) UNIT LOT: 108MBR. AS INDICATED, IN TWO OF THE UNITS, A SCARCELY PERCEPTIBLE PRESENCE OF THE BALEEN STRUCTURE OF THE MATERIAL WAS VISUALLY EVIDENCED, AN OBSERVATION MADE AT THE TIME OF HANDLING THE PRODUCT. THE SUTURES INVOLVED WERE USED DURING THE SURGICAL PROCEDURE, WITH NO ADVERSE EVENT, CLINICAL COMPLICATION, OR IMPACT ON PATIENT SAFETY REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED ASSOCIATED WITH THIS OBSERVATION. THE REPORT IS MADE AT THE REQUEST OF THE USER, FOR THE PURPOSES OF EVALUATION AND CORRESPONDING MONITORING. ALSO REQUESTS THAT SAMPLES FROM THE SAME BATCH BE SENT TO BE OPENED IN THE PRESENCE OF THE DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111350 ↗
• MalfunctionMay 7, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CLIENT REPORTS AN OBSERVATION RELATED TO STRATAFIX¿ 4-0 SUTURE ETHICON BRAND, CORRESPONDING TO THE FOLLOWING LOTS: 2 UNITS LOT 106BG7 AND 1 UNIT LOT 108MBR. AS INDICATED, IN TWO OF THE UNITS, A SCARCELY PERCEPTIBLE PRESENCE OF THE BALEEN STRUCTURE OF THE MATERIAL WAS VISUALLY EVIDENCED, AN OBSERVATION MADE AT THE TIME OF HANDLING THE PRODUCT. THE SUTURES INVOLVED WERE USED DURING THE SURGICAL PROCEDURE, WITH NO ADVERSE EVENT, CLINICAL COMPLICATION, OR IMPACT ON PATIENT SAFETY REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED ASSOCIATED WITH THIS OBSERVATION. THE REPORT IS MADE AT THE REQUEST OF THE USER, FOR THE PURPOSES OF EVALUATION AND CORRESPONDING MONITORING. ALSO REQUESTS THAT SAMPLES FROM THE SAME BATCH BE SENT TO BE OPENED IN THE PRESENCE OF THE DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111347 ↗
• MalfunctionMay 7, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CLIENT REPORTS AN OBSERVATION RELATED TO STRATAFIX¿ 4-0 SUTURE ETHICON BRAND, CORRESPONDING TO THE FOLLOWING LOTS: (B)(4) UNITS LOT 106BG7 AND (B)(4) UNIT LOT 108MBR. AS INDICATED, IN TWO OF THE UNITS, A SCARCELY PERCEPTIBLE PRESENCE OF THE BALEEN STRUCTURE OF THE MATERIAL WAS VISUALLY EVIDENCED, AN OBSERVATION MADE AT THE TIME OF HANDLING THE PRODUCT. THE SUTURES INVOLVED WERE USED DURING THE SURGICAL PROCEDURE, WITH NO ADVERSE EVENT, CLINICAL COMPLICATION, OR IMPACT ON PATIENT SAFETY REPORTED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED ASSOCIATED WITH THIS OBSERVATION. THE REPORT IS MADE AT THE REQUEST OF THE USER, FOR THE PURPOSES OF EVALUATION AND CORRESPONDING MONITORING. ALSO REQUESTS THAT SAMPLES FROM THE SAME BATCH BE SENT TO BE OPENED IN THE PRESENCE OF THE DOCTOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111341 ↗
• InjuryApr 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IN THE PAST WEEK THE PATIENT HAD SUTURE THAT SPIT OUT FROM THE HIP WOUND. SURGERY WAS 6-8 WEEKS AGO. WHEN THE HIP WAS REOPENED, THE SUTURE DID NOT DEGRADE OR ABSORB AT ALL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Pocket Erosion; Swelling/ Edema; Wound Dehiscence

  MAUDE report 24769035 ↗
• InjuryApr 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IN THE PAST WEEK THE PATIENT HAD SUTURE THAT SPIT OUT FROM THE HIP WOUND. SURGERY WAS 6-8 WEEKS AGO. WHEN THE HIP WAS REOPENED, THE SUTURE DID NOT DEGRADE OR ABSORB AT ALL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24768942 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A PLASTIC SURGERY SUTURES WERE BREAKING. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914318 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURES WERE BREAKING. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906015 ↗