Coated VICRYL J310HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031038677), received between Mar 28, 2019 and Mar 3, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC APPENDECTOMY UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S TISSUE. WHEN THE SUTURE WAS CLAMPED, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY REPLACED ANOTHER SUTURE TO CONTINUE SUTURING THE TISSUE, AND THE SURGERY PROCEEDED SMOOTHLY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501018 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS UED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609151 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609107 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, TIP OF THE SUTURE NEEDLE BROKE OFF WHILE SURGEON WAS REPOSITIONING SUTURE IN NEEDLE DRIVER. SURGEON WAS ABLE TO LOCATE TIP OF SUTURE THAT BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23558921 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PACKAGE WAS EMPTY WHEN JUST OPEN THE PACKAGE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, BUT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557296 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GALLBLADDER SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGERY WAS COMPLETED AND SUTURED, THE NEEDLE BROKE IN THE PATIENT'S MUSCLE TISSUE. AFTER SEARCHING, THE BROKEN NEEDLE IN THE PATIENT'S MUSCLE TISSUE HAS BEEN REMOVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463000 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPERNUMERARY TOOTH EXTRACTION SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY IN THE MORNING. DURING THE SUTURING PROCESS AFTER THE SURGERY WAS COMPLETED, THE SUTURE NEEDLE BROKE AND POPPED OUT. AFTER CAREFUL EXAMINATION OF THE ORAL CAVITY, IT WAS CONFIRMED THAT THE BROKEN END WAS NOT IN THE PATIENT'S MOUTH, CHANGED ANOTHER ONE FOR SUTURING AGAIN. AFTER THE TREATMENT IS COMPLETED, CAREFULLY SEARCH FOR THE BROKEN END OF THE NEEDLE AGAIN BEFORE THE PATIENT WAS RESUSCITATED, AND FOUND ON THE FLOOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316015 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A CHILD UNDERWENT A GENERAL ANESTHESIA SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY IN THE MORNING, THE PATIENT NEEDED TO REMOVE THE TOOTH THAT COULD NOT BE PRESERVED. DURING WOUND SUTURING, THE NEEDLE BROKE FROM THE WEAK POINT OF THE NEEDLE NOSE. FORTUNATELY, THE NEEDLE HOLDER WAS HOLDING THE NEEDLE AT THE TIME. SO, NO SERIOUS CONSEQUENCES SUCH AS SCRATCHING THE SKIN AND MUCOUS MEMBRANE OR FALLING INTO THE MOUTH WERE CAUSED. CHANGED ANOTHER ONE AND CONTINUE SUTURING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263973 ↗
• MalfunctionJun 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON USED SUTURE TO SEW THE SKIN, BUT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED , CAUSING THE NEEDLE TO BOUNCE. THEY SEARCHED IN THE SURGICAL AREA BUT WERE UNABLE TO FIND IT. THEY IMMEDIATELY REPORTED TO THE HEAD NURSE TO SEARCH TOGETHER AND FOUND IT AROUND THE OPERATING TABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524334 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EVEN THOUGH THE SURGEON DID NOT PULL THE SUTURE STRONGLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097548 ↗
• MalfunctionNov 2, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING A SURGICAL CONSTRUCTION OF SHUNT, WHEN A SCRUB NURSE OPENED THE PACKAGE OF J310H, A NEEDLE-SUTURE, MARKED W9140 ON THE TRAY, WAS IN THE PACKAGE. THEREFORE, ANOTHER PACKAGE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055961 ↗
• MalfunctionAug 8, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS NOT STERILIZED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484059 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE SUTURE BROKE OFF EASILY DURING INTERRUPTED SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567776 ↗
• MalfunctionFeb 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY A SUTURE BROKE DURING USE. THE PRODUCT WAS DISCARDED. ALSO, ANOTHER SUTURE WAS FRAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368590 ↗
• MalfunctionFeb 13, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY A SUTURE BROKE DURING USE. THE PRODUCT WAS DISCARDED. ALSO, ANOTHER SUTURE WAS FRAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368581 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS BROKEN DURING USE ON THE MAMMARY GLAND. THE BROKEN NEEDLE WENT UNDER SUBCUTANEOUSLY, AND IT WAS REMOVED IN THE SAME PROCEDURE BY USING THINGS SUCH AS A CAMERA. THE SUTURE METHOD USED WAS CONTINUOUS SUTURING. THE OPERATION TIME WAS EXTENDED MORE THAN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178514 ↗
• MalfunctionOct 28, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 10/5/2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE PART DURING USE ON THE ANUS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748821 ↗
• MalfunctionOct 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED EASILY FROM THE NEEDLE DURING USE ON THE ANUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748775 ↗
• InjuryOct 1, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEMORRHOID SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE HEMORRHOID SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING LIGATION OF THE HEMORRHOID ARTERY. THEN, THE NEEDLE REMAINED IN THE BODY. IT WAS REPORTED THAT THE BROKEN NEEDLE WAS LEFT IN THE BODY, SO RE-INSPECTION IS PLANNED. THE PATIENT IS CURRENTLY IN THE HOSPITAL. FOR REMOVAL OF THE NEEDLE AFTER DISCHARGE OF THE HOSPITAL, ADDITIONAL INSPECTION AND ADDITIONAL HOSPITALIZATION WILL BE PERFORMED. THE SURGEON OPINED NO NEEDLE PULL-OFF ISSUES OCCURRED WITH OTHER PACKAGES, AND THERE WAS NO PROBLEM WITH OTHER PACKAGES. THUS, THE SURGEON SUSPECTED THAT THERE MAY HAVE BEEN A PROBLEM WITH THE AFFECTED PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10614548 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591020 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC FALLOPIAN TUBE RECANALIZATION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN BROKEN IN THE NEWLY DISPENSED SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565268 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC FALLOPIAN TUBE RECANALIZATION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN BROKEN IN THE NEWLY DISPENSED SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565259 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC FALLOPIAN TUBE RECANALIZATION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN BROKEN IN THE NEWLY DISPENSED SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565256 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC FALLOPIAN TUBE RECANALIZATION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN BROKEN IN THE NEWLY DISPENSED SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565254 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ENTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS PULLING FROM THE SUTURE AFTER THE 1ST STITCH, IT WAS FOUND THAT THE SUTURE HAD BROKEN IN THE MIDDLE OF IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079274 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc