Coated VICRYL J269HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031038431), received between Sep 14, 2018 and Dec 29, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Material Frayed; Material Integrity Problem; Break; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE A SURGEON WAS USING THE SUTURE FOR CLOSURE, IT WAS ¿LIKE A KNOT AT END OF SUTURE¿. THE SUTURE FRAYED/FRAYS AT THE END WHEN PULLED & IT BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906060 ↗
• MalfunctionDec 29, 2025Break; Material Frayed; Material Integrity Problem; Break; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE A SURGEON WAS USING THE SUTURE FOR CLOSURE, IT WAS ¿LIKE A KNOT AT END OF SUTURE¿. THE SUTURE FRAYED/FRAYS AT THE END WHEN PULLED & IT BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906059 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE OFF FROM SUTURE X2 ON DEEP STITCHING. NEEDLE CAUGHT IN TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298553 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE OFF FROM SUTURE X2 ON DEEP STITCHING. NEEDLE CAUGHT IN TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298550 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO DL BY THE EMPLOYEE THAT WHEN USING IN SURGERY THE NEEDLE BROKE OFF. NO PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081938 ↗
• MalfunctionDec 27, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO BEND THE NEEDLE AND THE NEEDLE BROKE. BOTH HALVES OF THE NEEDLE RECOVERED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087626 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE SUTURING UNKNOWN TISSUE. SUTURE WAS DISCOVERED WHILE SEARCHING THE FLOOR AND SECURED FOR FURTHER INVESTIGATION. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12398226 ↗
• MalfunctionOct 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS NOT ABSORBING LONG AFTER IT IS SUPPOSED TO. THEY CHECKED BACK MONTHS LATER AND STILL FOUND SUTURE. STRAYS OF SUTURE LEFT ON PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10710889 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE DIAGNOSTIC SCOPE OPEN FLUOROSCOPY-GUIDED DEBRIDEMENT AND BONE GRAFTING OF DISTAL MEDIAL FEMORAL CONDYLE FOR AVASCULAR NECROSIS ON (B)(6) 2020 AND SUTURE WAS USED. ON THE FIRST POST-OPERATIVE VISIT THE PATIENT¿S INCISION WAS HEALING WELL AND THERE WERE NO CONCERNS. SIX WEEKS POST-OP THE PATIENT PRESENTED WITH COMPLAINTS OF HAVING ISSUES WITH THE MEDIAL INCISION AND SOME REDNESS THAT STARTED ONE WEEK PRIOR. ON CLINICAL EXAM, THERE WAS ABOUT 3 CM MEDIAL WOUND DELAYED HEALING AND NO DRAINAGE WAS NOTED. THE PATIENT WAS ADVISED TO START ANTIBIOTICS FOR 10 DAYS AND TO KEEP THE AREA CLEAN AND DRY. IT WAS REPORTED TO BE SUPERFICIAL IN APPEARANCE AND THERE HAS BEEN NO FOLLOW-UP YET WITH THE PATIENT. IT WAS REPORTED THAT THE PATIENT IS YOUNG, HEALTHY, AND NOT EXPECTING ANY WOUND ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Impaired Healing

  MAUDE report 10465244 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE ARTHROSCOPY WITH PATELLA TENDON AUTOGRAFT ACL RECONSTRUCTION, PARTIAL LATERAL MENISCECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. ABOUT SIX WEEKS POST-OP, THE PATIENT REPORTED WOUND HEALING VIA TELEPHONE AND THE PATIENT WAS STARTED ON ORAL ANTIBIOTICS. ON (B)(6) 2020 FOLLOW-UP APPOINTMENT, THE PATIENT SHOWED LEFT KNEE INCISION HEALING WITH THE EXCEPTION OF TWO SMALL AREAS WITH SOME MILD SUPERFICIAL ERYTHEMA AND A SMALL STITCH ABSCESS. THE PATIENT WAS ADVISED TO CONTINUE WITH ANTIBIOTICS. IT WAS REPORTED THE PATIENT IS YOUNG, HEALTHY AND NOT EXPECTED TO HAVE WOUND ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Erythema; Impaired Healing

  MAUDE report 10465226 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE OPEN QUADRICEPS TENDON REPAIR ON (B)(6) 2020 AND SUTURE WAS USED. ABOUT 5 WEEKS POST-OP, THE PATIENT PRESENTED WITH SOME BREAKDOWN OF WOUND CENTRALLY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND DAILY DRY DRESSING CHANGES. THE PATIENT¿S LAST CLINIC VISIT WAS (B)(6) 2020 AND THE WOUND WAS HEALING BY SECONDARY INTENTION AND PATIENT WAS UNDER CONTINUED OBSERVATION. IT WAS REPORTED THAT THE PATIENT WAS CASTED FOR THE FIRST 6 WEEKS AND WOUND ISSUES WERE CONCERNED FROM THE BEGINNING. THIS WAS ALSO NOT VIRGIN SKIN AND PATIENT HAD SEVERAL COMORBIDITIES WHICH PUT HER AT RISK FOR WOUND ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 10463193 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE OPEN PATELLA TENDON REPAIR WITH ALLOGRAFT ON (B)(6) 2020 AND SUTURE WAS USED. ON THE PATIENT¿S POST-OPERATIVE VISIT ON (B)(6) 2020, THE PATIENT WAS NOTED TO HAVE A MIDLINE BLOOD BLISTER AND WAS PLACED ON ANTIBIOTICS. ON (B)(6) 2020, THE PATIENT WOUND WAS NOTED TO BE OPENING UP MORE DISTALLY WITH DRAINAGE. CLINICAL EXAM NOTED REDNESS AND OPENING APPROXIMATELY 7-8 MM IN DIAMETER. THE PATIENT WAS ADVISED TO CONTINUE DRESSING CHANGES AND ANTIBIOTIC. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON. THE PATIENT EXPERIENCED CONTINUED WOUND PROBLEMS OVER THE NEXT WEEK. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AND UNDERWENT THREE I&D¿S AND FINAL WOUND CLOSURE WITH GASTRIC FLAP PERFORMED BY A PLASTIC SURGEON. IT WAS REPORTED THAT THE PATIENT WAS CONSIDERED HIGH RISK FOR WOUND PROBLEMS AND HAS HAD SEVERAL SURGERIES DECADES AGO TO THIS KNEE AND SEVERAL PRIOR INCISIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 10461495 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE OPEN PATELLA TENDON REPAIR WITH ALLOGRAFT ON (B)(6) 2020 AND SUTURE WAS USED. ON THE PATIENT¿S POST-OPERATIVE VISIT ON (B)(6) 2020, THE PATIENT WAS NOTED TO HAVE A MIDLINE BLOOD BLISTER AND WAS PLACED ON ANTIBIOTICS. ON (B)(6) 2020, THE PATIENT WOUND WAS NOTED TO BE OPENING UP MORE DISTALLY WITH DRAINAGE. CLINICAL EXAM NOTED REDNESS AND OPENING APPROXIMATELY 7-8 MM IN DIAMETER. THE PATIENT WAS ADVISED TO CONTINUE DRESSING CHANGES AND ANTIBIOTIC. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON. IT WAS REPORTED THAT THE PATIENT WAS CONSIDERED HIGH RISK FOR WOUND PROBLEMS AND HAS HAD SEVERAL SURGERIES DECADES AGO TO THIS KNEE AND SEVERAL PRIOR INCISIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Wound Dehiscence

  MAUDE report 10461493 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE OPEN PATELLA TENDON REPAIR WITH ALLOGRAFT ON (B)(6) 2020 AND SUTURE WAS USED. ON THE PATIENT¿S POST-OPERATIVE VISIT ON (B)(6)2020, THE PATIENT WAS NOTED TO HAVE A MIDLINE BLOOD BLISTER AND WAS PLACED ON ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENT WAS CONSIDERED HIGH RISK FOR WOUND PROBLEMS AND HAS HAD SEVERAL SURGERIES DECADES AGO TO THIS KNEE AND SEVERAL PRIOR INCISIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Tissue Damage

  MAUDE report 10461489 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE OPEN CONTRACTURE RELEASE AND OPEN REDUCTION AND INTERNAL FIXATION OF PATELLA FRACTURE ON (B)(6) 2020 AND THE SUTURE WAS USED. AT SECOND POSTOPERATIVE VISIT ON 7/30/2020 IT WAS NOTED THE INCISION WAS HEALING BUT HAD SMALL AREAS OF SCAB. THERE WERE CONCERNS THE WOUND WAS STARTING TO BREAK OPEN. 2 DAYS LATER, PATIENT CONTACTED THE SURGEON DUE TO MIDLINE INCISION STARTING TO BREAK DOWN. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED ABSCESS AND WOUND DEHISCENCE. THE PATIENT WAS ADVISED TO START DAILY DRY DRESSING CHANGES AND STARTED ANTIBIOTICS. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 10458165 ↗
• MalfunctionMay 29, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE WHILE PUTTING THE NEEDLE INTO THE TROCAR. ADDITIONAL SUTURE FROM ANOTHER LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650615 ↗
• MalfunctionMay 28, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE WHILE PUTTING THE NEEDLE INTO THE TROCAR. ADDITIONAL SUTURE FROM ANOTHER LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647293 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ONCE THE WOUND WAS STARTING TO HEAL, THE DOCTOR REPORTED BUILDUP OF FLUID AND NECESSARY WOUND WASH OUT BEING PERFORMED TO CLEAN AFFECTED AREA AND REAPPROXIMATE WOUND EDGES. SPECIFIC ISSUES, SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING WERE POSSIBLE BUT SPECIFICS WEREN'T REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable; Swelling; Unspecified Infection

  MAUDE report 8638259 ↗
• MalfunctionSep 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP THE PATIENT COMPLAINED OF SPITTING SUTURE PRIOR TO THE TWO WEEK POST-OP VISIT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7894993 ↗
• MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OPERATIVELY, THE ABSORBABLE SUTURE WAS NOT ABSORBING, AND THE SUTURE WAS "SPITTING THROUGH THE SKIN". IT IS UNKNOWN HOW OR IF THE PATIENT WAS TREATED FOR THIS CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7884889 ↗
• MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OPERATIVELY, THE ABSORBABLE SUTURE WAS NOT ABSORBING, AND THE SUTURE WAS "SPITTING THROUGH THE SKIN". IT IS UNKNOWN HOW OR IF THE PATIENT WAS TREATED FOR THIS CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7884832 ↗
• MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OPERATIVELY, THE ABSORBABLE SUTURES WERE NOT ABSORBING, AND THE SUTURES WERE "SPITTING THROUGH THE SKIN". IT IS UNKNOWN HOW OR IF THE PATIENT WAS TREATED FOR THIS CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7884819 ↗
• MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OPERATIVELY, THE ABSORBABLE SUTURES WERE NOT ABSORBING, AND THE SUTURES WERE "SPITTING THROUGH THE SKIN". IT IS UNKNOWN HOW OR IF THE PATIENT WAS TREATED FOR THIS CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 7884812 ↗
• MalfunctionSep 14, 2018Break

  DURING SURGERY, TINY TIP OF NEEDLE BROKE OFF. CT AND XRAY DONE. NO FOREIGN BODY WAS FOUND. MD DISCLOSED TO THE PATIENT. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876239 ↗