STRATAFIX SXPP1A306Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031245228), received between Mar 4, 2020 and May 1, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL CLOSURE PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING HEPATOBILIARY AND PANCREATIC SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN SXPP1A306 WAS USED FOR FASCIAL CLOSURE. THE SITUATION WAS THAT AS THE WOUND WAS SUTURED AT THE END OF THE SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE STITCHES WERE PULLED. AT THAT POINT, THE SUTURE WAS CUT AND THE WOUND WAS CLOSED BY OVERLAPPING THE AREA WITH VCPB725D. THE PRODUCT HAS BEEN DISCARDED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. .NO SAMPLE WILL BE RETURNED. 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 25058439 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE RECTUS SHEATH. POST-OP, THE PATIENT HAD A WOUND WITH A COMPLEX RECOVERY FOR A PATIENT OTHERWISE LOW-RISK. IMMEDIATE POST-OP RECOVERY WAS STRAIGHTFORWARD AND DISCHARGED HOME DAY 2 POST-OP. DAY 9 (B)(6) 2025): REATTENDED WITH WOUND INFECTION. ERYTHEMA AND INDURATION TO WOUND, 2 DEHISCENCE DRAINING PURULENT FLUID. TREATED WITH IV ANTIBIOTICS AND 2 X DRAINAGE BAGS APPLIED TO DEHISCENCE. DISCHARGED HOME (B)(6) WITH WOUND CLINIC FOLLOW UP. PATIENT REVIEWED (B)(6) 2025 IN WOUND CLINIC. THERE WAS EXPECTED WOUND HEALING, DISCHARGED, INCISION HEALED. ON (B)(6) 2025: THE PATIENT REPRESENTS TO WOUND CLINIC WITH HAEMOSEROUS FLUID LEAKING FROM CENTRE OF WOUND. OE PINPRICK GAPE AND SMALL BULLA. DRESSED AND FOR OP FOLLOW UP. ON (B)(6) 2025: CHRONIC WOUND AT SITE OF POST-OP CAESAREAN SECTION INCISION. ON (B)(6) 2025: BULLA TO RIGHT ASPECT OF WOUND, EARLY STAGES OF OVER-GRANULATION 0.2 X 0.2CM. DRESSED AND FOR CONSIDERATION OF SILVER NITRATE AT NEXT APPOINTMENT. ON 23-DEC-2025: 3CM X 0.25CM NON-VIABLE GRANULATION TISSUE OOZING HAEMOSEROUS FLUID. 0.75CM CAVITY BELOW. UNDER LOCAL ANAESTHETIC, TISSUE

  Patient problems: Blister; Erythema; Fluid Discharge; Granuloma; Impaired Healing; Pocket Erosion; Post Operative Wound Infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 24393389 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS BROKEN. THE ISSUE HAS OCCURRED, BUT THE DETAILS ARE UNKNOWN AT THIS TIME, SO WILL BE ADDED AS ADDITIONAL INFORMATION BECOMES AVAILABLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350394 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT PART OF THE FIXATION TAB MAY HAVE BEEN MISSING. IT WAS SOMEWHAT UNCLEAR AS TO WHETHER IT WAS A DEFINITE CASE OF THIS. WHEN THEY CHECKED THE WOUND AFTER THE REGISTRAR HAD CLOSED IT, IT SEEMED HALF OF THE TAB WAS NOT VISIBLE. IN MY EXPERIENCE IT MAY BE THAT IT WAS PARTIALLY COVERED BY FATTY TISSUE. IT DID NOT FURTHER IMPACT THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046370 ↗
• MalfunctionMay 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON (B)(6)2023 AND BARBED SUTURE WAS USED. AT THE END OF THE SURGERY, ON THE FIRST STITCH OF THE RETURN STITCH, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE SUTURE WAS ATTACHED TO THE DECAPITATOR NEEDLE, TWO RETURN STITCHES WERE MADE, AND THE SURGERY WAS COMPLETED. THE SURGEON SAID, "MAYBE I PULLED THE SUTURE TOO HARD BECAUSE I WAS TIRED. WHEN I USED PRODUCT IN THE NEXT SURGERY AFTER THAT, IT WAS FINE, SO I THINK IT WAS MY PROBLEM AS THE PERSON USING IT." IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010216 ↗
• MalfunctionFeb 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. WHEN THE SURGEON PUT THE FIRST STITCH ON FASCIA AND PULLED THE NEEDLE-SUTURE, THE NEEDLE WAS DETACHED FROM THE SUTURE AS IF IT HAD BEEN A CONTROL RELEASE NEEDLE. HOWEVER, IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED AND THEN THE SAME THING HAPPENED AGAIN. THIRD PRODUCT WAS USED WITHOUT ANY PROBLEMS. THE SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362222 ↗
• MalfunctionFeb 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. WHEN THE SURGEON PUT THE FIRST STITCH ON FASCIA AND PULLED THE NEEDLE-SUTURE, THE NEEDLE WAS DETACHED FROM THE SUTURE AS IF IT HAD BEEN A CONTROL RELEASE NEEDLE. HOWEVER, IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED AND THEN THE SAME THING HAPPENED AGAIN. THIRD PRODUCT WAS USED WITHOUT ANY PROBLEMS. THE SUTURE METHOD WAS CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362200 ↗
• MalfunctionNov 8, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752654 ↗
• MalfunctionNov 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE DURING SUTURING. THE PRODUCT WAS DISCARDED. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710812 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING SUTURING ON FASCIA. ANOTHER PRODUCT WAS USED BUT THE SAME THING HAPPENED AGAIN. THE PRODUCTS WERE DISCARDED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705359 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING SUTURING ON FASCIA. ANOTHER PRODUCT WAS USED BUT THE SAME THING HAPPENED AGAIN. THE PRODUCTS WERE DISCARDED. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705320 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE FASCIA. POST-OP, A WOUND DEHISCENCE OCCURRED. THEREFORE, RE-OPERATION WAS PERFORMED. AFTER THE REOPERATION, THE PATIENT'S CONDITION HAS BEEN STABLE. THE SURGEON OPINED THAT THE CAUSE OF THE DEHISCENCE WAS THE WAY THE SUTURE WAS APPLIED TO THE TISSUE AND THE LENGTH OF THE SUTURE APPLIED TO THE MUSCLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15692541 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING WOUND CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518901 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509652 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509353 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING WOUND CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474070 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY ON (B)(6) 2022 AND A BARBED SUTURE WAS USED ON FASCIA. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798370 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY ON (B)(6) 2022 AND A BARBED SUTURE WAS USED ON FASCIA. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798363 ↗
• InjuryJun 13, 2022Adverse 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 (B)(6) 2022 AND A BARBED SUTURE WAS USED FOR CONTINUOUS SUTURING. ON POSTOPERATIVE DAY 6, WOUND DEHISCENCE OCCURRED. REOPERATION WAS PERFORMED ON (B)(6) 2022. CURRENT STATUS OF THE PATIENT AT THE TIME OF REPORT WAS BEING IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14674441 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DOUBLE MASTECTOMY WITH DIEP FLAP APPROXIMATELY (B)(6) 2021 AND THE BARBED SUTURE WAS USED ON FASCIA OR POSSIBLE DEEP DERMAL. THE TISSUE CONDITION WAS NORMAL FOR AGE AND BMI. POST-OPERATIVELY, ABDOMINAL CLOSURE WAS PRESENTING A GREAT SKIN CLOSURE BUT LIQUIFIED FAT HAS CREPT TO THE SURFACE CAUSING WOUND COMPROMISE AND DEHISCENCE. IT WAS REPORTED THAT THE BARBED SUTURE WAS ONLY USED IN CENTRAL PORTION OF INCISION WHERE THERE WAS AN ISSUE. IT WAS ALSO REPORTED THAT THE CHANNELS OF THE GOOD INTACT SUTURE LINE COULD BE OBSERVED WHERE IT LOOKS LIKE THE FAT HAS LIQUIFIED AROUND IT. THE FATTY LAYER DEHISCED APPROXIMATELY ON POST-OP DAY 28TH AND THE DEEP DERMAL AND SKIN WOUND WERE RE-SUTURED WITH OTHER TYPE SUTURE ALSO APPROXIMATELY ON POST-OP DAY 28TH. THERE WERE NO FURTHER COMPLICATIONS. SURGEON STATED THAT THE PATIENT WAS ALLERGIC TO EVERYTHING AND WAS ALWAYS A TESTING CASE ACROSS ALL ASPECTS OF HER SURGERY, HENCE THERE WAS NO IMMEDIATE CONTACT WITH SURGEON. THE SURGEON OPINED THAT IT WAS POSSIBLE OVER TIGHTENING WITH SUTURE AND PERHAPS SLIGHT OVER STRANGULATION OF TISSUE MAY BE CONTRIBUTING FACTOR BUT NOT ROOT CAUSE. THE PATIENT IS DOING WELL,

  Patient problems: Wound Dehiscence

  MAUDE report 12317177 ↗
• InjuryMar 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT COLECTOMY AND STOMA CLOSURE ON (B)(6) 2020 AND BARBED SUTURE WAS USED FOR CLOSING THE SURGICAL WOUND ON THE ABDOMEN BY CONTINUOUS SUTURING. THE PERITONEUM AND FASCIA WERE SUTURED TOGETHER. POST-OP, ASCITIC FLUID ACCUMULATED AND THE AREA AT THE SURGICAL WOUND GOT SWOLLEN. EMERGENCY REOPERATION WAS PERFORMED. THEN, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN, AND WOUND DEHISCENCE HAD OCCURRED. THE AFFECTED SITE WAS RE-SUTURED. THE PATIENT HAD BEEN IN THE HOSPITAL UNDER FOLLOW-UP OBSERVATION AFTER THE SURGERY. BUT HEART FAILURE OCCURRED, SO, HE HAS BEEN ON AN ARTIFICIAL VENTILATOR SINCE THEN. IT WAS REPORTED THAT THE SURGEON OPINED SINCE THE SUTURE WAS PULLED WITH FORCEPS, THERE WAS A POSSIBILITY THAT THE SUTURE WAS HURT. THE SURGEON ALSO OPINED THAT SINCE THE PATIENT HAD TENDENCY OF DEMENTIA, THERE IS A POSSIBILITY THAT EXTRA TENSION WAS APPLIED TO THE SUTURE WHEN PATIENT MOVED CARELESSLY. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE ASCITES IS NOT CAUSED BY THE SUTURE BUT BY THE WOUND DEHISCENCE AND THE CAUSE OF THE HEART FAILURE IS PROBABLY TWO SURGERIES IN A SHORT PERIOD OF TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable; Swelling

  MAUDE report 9853555 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SWAGE SITE. ANOTHER ONE WAS OPENED TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788697 ↗