STRATAFIX SXPP1B416Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10705031235892), received between Feb 9, 2018 and May 13, 2026 — classified as 11 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SURGERY, THE LOOP WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161472 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A ROBOTIC INGUINAL HERNIA PROCEDURE, WHEN THE SURGEON WAS APPROXIMATING AND PULLING THROUGH THE APPROXIMATE THE SUTURE SNAPPED. THEY OPENED ANOTHER ONE HOWEVER THE RESULTS WERE THE SAME. NO PATIENT CONSEQUENCES REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095933 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A ROBOTIC INGUINAL HERNIA PROCEDURE, WHEN THE SURGEON WAS APPROXIMATING AND PULLING THROUGH THE APPROXIMATE THE SUTURE SNAPPED. THEY OPENED ANOTHER ONE HOWEVER THE RESULTS WERE THE SAME. NO PATIENT CONSEQUENCES REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095930 ↗
• MalfunctionDec 16, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. I DID A FACE LIFT THE OTHER WEEK AND USED BARBED SUTURE. IT DID NOT SEEM TO SHOW MUCH IN THE WAY OF BARBS AND DID NOT GRIP AS WELL AS I AM USED TO. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819232 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT IS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977232 ↗
• MalfunctionDec 2, 2024Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6)2024 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS USED DURING AN ORTHOPEDIC PROCEDURE TO CLOSE DEEP DERMAL / SUB Q TISSUE. THE SUTURE WAS INITIATED APPROPRIATELY AND RUN THE LENGTH OF THE INCISION. THREE BACK STITCHES WERE PLACED. A LAP SPONGE WAS USED TO DAB THE INCISION FROM OOZING PRIOR TO CLOSING THE NEXT LAYER. UPON GENTLY DABBING THE INCISION, THE SUTURE BACKED OUT MULTIPLE THROWS REQUIRING ADDITIONAL SUTURES TO BE PLACED TO SUPPORT THE INCISION. THE CST IN THE ROOM INSPECTED THE SUTURE AND MENTIONED THAT THE SUTURE SEEMED LIKE IT WAS SIGNIFICANTLY LESS BARBED THAN USUAL. IT WAS ABLE TO ASSESS THE SUTURE IN PERSON AND ALSO AGREED THAT IT SEEMS LIKE THE BARBS ARE NOT AS PRONOUNCED AS NORMAL AND GIVEN THE SLIPPAGE IN THE TISSUE, WE DECIDED TO FILE A REPORT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819389 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6)2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, AFTER ADVANCING ABOUT 4 STITCHES ON A HORIZONTAL MATTRESS, THE SUTURE WAS BROKEN AT THE SWAGE PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199709 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR SUTURING THE KIDNEY BED AFTER THE RESECTION. POST-OP, ON THE 2ND DAY AFTER THE PROCEDURE, AN INCREASE IN TEMPERATURE TO 38 DEGREES WAS OBSERVED FOR TWO DAYS. AFTER ANTIBIOTIC THERAPY WAS PRESCRIBED ON THE 2ND DAY, THE TEMPERATURE DECREASED, AND EVEN WITHOUT ANTIBIOTIC THERAPY THE TEMPERATURE ALSO DECREASED AFTER 2 DAYS. A FULL BLOOD COUNT, BIOCHEMICAL BLOOD TEST, AND COAGULOGRAM WERE DONE. APART FROM FEVER, NO OTHER SYMPTOMS WERE OBSERVED. THE PATIENT RECEIVED AN INFUSION OF STREFUNDIN 500 ML AND 4 MG DEXAMETHASONE INTRAVENOUSLY. THE PATIENT'S CONDITION IS CURRENTLY STABLE AND SATISFACTORY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever

  MAUDE report 19557601 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY OPERATION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE CYSTOURETHROANASTOMOSIS. POST-OP, THE PATIENT HAD AN INCREASE IN TEMPERATURE TO 38 DEGREES FOR TWO DAYS ON THE 2ND DAY. WITHOUT ANTIBIOTIC THERAPY, THE TEMPERATURE DECREASED AFTER 2 DAYS. AFTER ANTIBIOTIC THERAPY WAS PRESCRIBED, ON THE 2ND DAY THE TEMPERATURE ALSO DECREASED. A FULL BLOOD COUNT, BIOCHEMICAL BLOOD TEST, AND COAGULOGRAM WERE DONE. APART FROM FEVER, NO OTHER SYMPTOMS WERE OBSERVED. THE PATIENT RECEIVED AN INFUSION OF STREFUNDIN 500 ML AND 4 MG DEXAMETHASONE INTRAVENOUSLY. THE PATIENT'S CONDITION IS CURRENTLY STABLE AND SATISFACTORY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever

  MAUDE report 19557595 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY OPERATION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE CYSTOURETHROANASTOMOSIS.. POST-OP, THE PATIENT HAD AN INCREASE IN TEMPERATURE TO 38 DEGREES FOR TWO DAYS ON THE 2ND DAY. WITHOUT ANTIBIOTIC THERAPY, THE TEMPERATURE DECREASED AFTER 2 DAYS. AFTER ANTIBIOTIC THERAPY WAS PRESCRIBED, ON THE 2ND DAY THE TEMPERATURE ALSO DECREASED. A FULL BLOOD COUNT, BIOCHEMICAL BLOOD TEST, AND COAGULOGRAM WERE DONE. APART FROM FEVER, NO OTHER SYMPTOMS WERE OBSERVED. THE PATIENT RECEIVED AN INFUSION OF STREFUNDIN 500 ML AND 4 MG DEXAMETHASONE INTRAVENOUSLY. THE PATIENT'S CONDITION IS CURRENTLY STABLE AND SATISFACTORY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever

  MAUDE report 19557589 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED ON THE DERMIS. THREE MONTHS AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF REDNESS AND ITCHING AT THE WOUND SITE. THE PATIENT WAS PRESCRIBED STEROID TAPE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 18851624 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL SURGERY PROCEDURE IN 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE USING IT IN A GENERAL SURGERY PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104189 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL SURGERY PROCEDURE IN 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE USING IT IN A GENERAL SURGERY PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104075 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2023 AND A BARBED SUTURE WAS USED FOR WOUND CLOSURE. THE PRODUCT WAS USED ON SUBCUTANEOUS DERMIS AND THE SUTURE METHOD WAS CONTINUOUS SUTURE. POST-OP, SKIN REDNESS OCCURRED AROUND 2 WEEKS AFTER THE SURGERY. THE REDNESS OCCURRED MAINLY IN THE FOLLOWING AREAS. THE AREA WHERE THE NEEDLE PENETRATED THE LAST SKIN AND CUT FROM THE BASE OF THE SUTURE. (THE AREA WHERE THE STITCH END.). THE SYMPTOM ABATED ONE WEEK AFTER ANTIBIOTIC WAS ADMINISTERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema

  MAUDE report 17700049 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC TOTAL HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED AS CONTINUOUS SUTURE ON THE VAGINAL CUFF. POST-OP, HEMORRHAGE OCCURRED. AFTER SURGERY, WHEN THE PATIENT STARTED WALKING, THERE WAS BLOOD COMING FROM THE VAGINA. THE BLEEDING SITE WAS ADDITIONALLY SUTURED TRANSVAGINALLY. THE SURGEON OPINED THAT, BECAUSE THE BLEEDING OCCURRED WHEN THE PATIENT STARTED WALKING, THE SURGEON THINKS THAT WHEN THE WOUND MOVED, THE BLEEDING OCCURRED. THE SURGEON DOESN¿T THINK THAT THE PRODUCT WAS RELATED TO THIS EVENT DIRECTLY. BECAUSE THE BLEEDING OCCURRED ON THE LOOP PLACEMENT SIDE, THE LOOP MIGHT NOT HAVE BEEN PROPERLY PLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 15941817 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC TOTAL HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. FOR CONTINUOUS SUTURE ON THE VAGINAL CUFF. POST-OP, IN THE WARD/ICU, HEMORRHAGE OCCURRED. AFTER SURGERY, WHEN THE PATIENT STARTED WALKING, THERE WAS BLOOD COMING FROM VAGINA. BECAUSE THE AMOUNT OF HEMORRHAGE WAS SMALL, THE CONDITION WAS MONITORED, AND THERE WAS NO HEMORRHAGE AT PRESENT. THERE WERE NO PARTICULAR PROBLEMS. THE SURGEON OPINED THAT BECAUSE THE BLEEDING OCCURRED WHEN THE PATIENT STARTED WALKING, THE SURGEON THINKS THAT WHEN THE WOUND MOVED, THE BLEEDING OCCURRED. THE SURGEON DOESN¿T THINK THAT THE PRODUCT WAS RELATED TO THIS EVENT DIRECTLY. LOOSENING OF THE LOOP MAY HAVE BEEN THE CAUSE. BECAUSE THE BLEEDING OCCURRED ON THE LOOP PLACEMENT SIDE, THE LOOP MIGHT NOT HAVE BEEN PROPERLY PLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15941787 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. WHEN THE SURGEON TRIED TO INSERT THE NEEDLE FROM THE TROCAR, THE NEEDLE GOT CAUGHT IN THE TROCAR AND BROKE. THE BROKEN NEEDLE TIP FELL INTO THE BODY THROUGH THE TROCAR, BUT COULD BE REMOVED WITHOUT LOSING SIGHT BECAUSE THE CAMERA CAPTURED THE NEEDLE TIP. THE PRODUCT WAS SUPPOSED TO USE FOR VAGINAL CUFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633818 ↗
• MalfunctionJul 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE THREAD CAME OFF OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028644 ↗
• MalfunctionJun 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING THE RETURN REVISION OF STRATAFIX SUTURES FROM THE DISTRIBUTOR A NON-AUTHORIZED LABELING ON SECONDARY PACKAGING WAS NOTED. THE DISTRIBUTOR CONFIRM THAT THE PRODUCTS INVOLVED WERE LABELING BY THEM. THE FOLLOWING DATA WERE ADDED BY THE DISTRIBUTOR AS PART OF LABELING: STORAGE CONDITIONS: SANITARY LICENSE, LOT, QR CODE, AND DATA IMPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761532 ↗
• MalfunctionJun 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING THE RETURN REVISION OF STRATAFIX SUTURES FROM THE DISTRIBUTOR A NON-AUTHORIZED LABELING ON SECONDARY PACKAGING WAS NOTED. THE DISTRIBUTOR CONFIRM THAT THE PRODUCTS INVOLVED WERE LABELING BY THEM. THE FOLLOWING DATA WERE ADDED BY THE DISTRIBUTOR AS PART OF LABELING: STORAGE CONDITIONS, SANITARY LICENSE, LOT, QR CODE AND, DATA IMPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761374 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005542 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING CLINICAL TRIAL THAT THE PATIENT UNDERWENT A BARIATRIC SLEEVE GASTRECTOMY ON (B)(6) 2021 AND THE BARBED SUTURE WAS USED FOR REINFORCEMENT OF THE STAPLE LINE. ON (B)(6) 2021, THE PATIENT EXPERIENCED SOB AND STOMACH PAIN AND WAS ADMITTED RESULTED WITHOUT MEDICAL OR SURGICAL INTERVENTION. DIAGNOSTIC IMAGING OBSERVATION WAS DONE. OUTCOME RECOVERED/RESOLVED ON (B)(6) 2021. IT WAS REPORTED THAT THE CHEST PAIN WAS POSSIBLY RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. ON (B)(6) 2021 THE PATIENT WAS HOSPITALIZED FOR PERFORATED GASTRIC SLEEVE. DURING REPAIR PROCEDURE, THE SAME SUTURES WERE USED, THE INITIAL BARBED SUTURE WAS NOT REMOVED. THE IPERACILLIN/TAZOBACTAM 3.365G 50ML INTRAVENOUS INFUSION OVER 4 HOURS AS 3 TIMES DAILY STARTED ON (B)(6) 2021. IN ADDITION, MOMETASONE/FORMOTEROL 200 UG/5UG INHALER 2 PUFFS TWICE A DAY WAS GIVEN. THE PATIENT IS STILL IN THE HOSPITAL AND RECOVERING WELL. IT WAS REPORTED THAT THE LEAKAGE WAS POSSIBLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE DEVICE. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Adult Respiratory Distress Syndrome; Failure to Anastomose; Nausea; Pain; Vomiting

  MAUDE report 12238798 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHILE TIGHTENING. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014282 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHILE TIGHTENING. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014280 ↗
• MalfunctionMay 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VERTICAL SLEEVE GASTRECTOMY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE DETACHED FROM THE SHAFT WHILE MANIPULATING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808954 ↗