Coated VICRYL J311HRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10705031038691), received between Aug 28, 2018 and May 4, 2026 — classified as 8 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (34 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN TRIED TO PASS THROUGH THE TISSUE AND APPLY TENSION DURING USE. THE PRODUCT WAS DISCARDED BECAUSE THE PRODUCT HAD A CONSIDERABLE AMOUNT OF BLOOD ON IT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 25070972 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE AT THE SWAGE PART WAS BROKEN WHEN THE PRODUCT WAS OPENED DURING SUTURING. NO PIECES WERE LEFT INSIDE THE PATIENT BECAUSE THE BROKEN NEEDLE TIP HAS BEEN RECOVERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058846 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE AT THE SWAGE PART WAS BROKEN WHEN THE PRODUCT WAS OPENED DURING SUTURING. NO PIECES WERE LEFT INSIDE THE PATIENT BECAUSE THE BROKEN NEEDLE TIP HAS BEEN RECOVERED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058845 ↗
• MalfunctionApr 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING. 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 24824226 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. THE SUTURE THREAD WITH THE FOLLOWING DESCRIPTION OF WHAT HAPPENED: "NEEDLE BROKE FROM THE THREAD AT THE MOMENT THE SUBCUTANEOUS WAS BEING CLOSED, THREAD CAME OUT OF THE TISSUE AND THE NEEDLE REMAINED. THE NEEDLE WAS REMOVED FROM THE CAVITY DURING THE INITIAL PROCEDURE WITHOUT HARM TO THE PATIENT. THERE WAS NO CHANGE IN THE PATIENT'S CONDITION DUE TO THIS EPISODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415532 ↗
• MalfunctionDec 16, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE PREPARING THE INSTRUMENT, WHEN THE NEEDLE-SUTURE WAS PUT ON THE INSTRUMENT TABLE, IT WAS FOUND THAT THE NEEDLE WAS DOUBLE-ARMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818341 ↗
• MalfunctionDec 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING AT THE SKIN, THE NEEDLES WERE BROKEN AT THE SWAGE PART THREE TIMES IN A ROW EVEN THOUGH IT WAS USED AS USUAL. SAFE AND PROPER USE MUST ALSO BE CONFIRMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23715567 ↗
• MalfunctionOct 6, 2025Break; Product Quality Problem; Defective Component; Structural Problem; Break; Product Quality Problem; Defective Component; Structural Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOSCOPIC MALIGNANT TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT DURING THE SURGERY USING MULTIPLE SUTURES, THE SUTURES AND NEEDLES OF THE TWO PRODUCTS INVOLVED WERE NOTICEABLY THINNER THAN USUAL, AND A SUTURE BREAKAGE HAD OCCURRED. ADDITIONAL SUTURES FROM ANOTHER PACKAGE WERE USED TO COMPLETE THE SURGERY, BUT THE DOCTOR HAS QUESTIONS ABOUT THE QUALITY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23224505 ↗
• MalfunctionOct 6, 2025Break; Product Quality Problem; Defective Component; Structural Problem; Break; Product Quality Problem; Defective Component; Structural Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOSCOPIC MALIGNANT TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT DURING THE SURGERY USING MULTIPLE SUTURES, THE SUTURES AND NEEDLES OF THE TWO PRODUCTS INVOLVED WERE NOTICEABLY THINNER THAN USUAL, AND A SUTURE BREAKAGE HAD OCCURRED. ADDITIONAL SUTURES FROM ANOTHER PACKAGE WERE USED TO COMPLETE THE SURGERY, BUT THE DOCTOR HAS QUESTIONS ABOUT THE QUALITY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23224500 ↗
• MalfunctionJun 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 22238532 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION UNDER EPIDURAL ANESTHESIA PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 18:46 DUE TO THE APPEARANCE OF REDNESS IN THE SECOND FULL-TERM PREGNANCY. DUE TO THE PRESENCE OF BIRTH SIGNS IN THE SCARRED UTERUS RELATIVE TO THE HEAD AND PELVIS, THE PATIENT UNDERWENT SURGERY AT 9:00 ON THE FIRST DAY OF ADMISSION. DURING INTRADERMAL SUTURING AT 9:35 DURING THE OPERATION, THE DISTAL END OF THE SUTURE BROKE, AND THE BROKEN SUTURE HEAD WAS DISCARDED AND SUTURED AGAIN. THIS EVENT RESULTED IN AN EXTENSION OF THE SURGERY TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071246 ↗
• MalfunctionMar 17, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. AT 10:20 AM, DURING THE PROCESS OF SUTURING THE INCISION FOR THE PARTURIENT, THE SUTURE BROKE AND THE HEAD OF THE SUTURE RETRACTED, RESULTING IN BLEEDING FROM THE INCISION. THE SURGEON IMMEDIATELY TOOK NEW SUTURES AND URGENTLY RE SUTURED THE WOUND. SUBSEQUENTLY, INCREASE MONITORING OF THE VITAL SIGNS AND INCISIONS OF THE PARTURIENT, AND PAY ATTENTION TO THE HEALING OF THE SUTURE SITE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21621466 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307663 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307660 ↗
• MalfunctionDec 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE LOOSENED FROM THE WIRE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820302 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, THE NEEDLE WAS UNUSUALLY BENT. DURING ANALYSIS OF THE RETURNED PRODUCT, THE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179162 ↗
• MalfunctionJul 16, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, IT WAS FOUND THAT THE NEEDLE WAS NOT ATTACHED FROM THE BEGINNING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750667 ↗
• MalfunctionJul 16, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, IT WAS FOUND THAT THE NEEDLE WAS NOT ATTACHED FROM THE BEGINNING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750661 ↗
• MalfunctionApr 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, A BLACK FOREIGN MATTER WAS FOUND INSIDE THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159730 ↗
• MalfunctionNov 15, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142030 ↗
• MalfunctionNov 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER USING THE DEVICE IN THE BODY CAVITY, THE SURGEON TRIED TO PULL THE NEEDLE-SUTURE OUT OF THE 12 MM PORT AND THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE FELL INTO THE BODY BUT WAS REMOVED WITHOUT LOSING SIGHT OF IT. THE SUTURE METHOD WAS CONTINUOUS SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046106 ↗
• MalfunctionNov 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER USING THE DEVICE IN THE BODY CAVITY, THE SURGEON TRIED TO PULL THE NEEDLE-SUTURE OUT OF THE 12 MM PORT AND THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE FELL INTO THE BODY BUT WAS REMOVED WITHOUT LOSING SIGHT OF IT. THE SUTURE METHOD WAS CONTINUOUS SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046105 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC COLOSTOMY CLOSURE ON (B)(6) 2023 AND SUTURE WAS USED ON THE INTRAPERITONEAL VIA CONTINUOUS METHOD. THE NEEDLE WAS BROKEN AT THE NEEDLE HOLDER WHEN THE SURGEON TRIED TO MOVE THE NEEDLE TO STITCH THE INTESTINAL TRACT. THE BROKEN NEEDLE WAS FOUND AND THERE WAS NO EFFECT ON THE SURGERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984666 ↗
• MalfunctionApr 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WITH USE, THEN THE NEEDLE FLIED. THE NEEDLE FELL INTO THE SURGICAL FIELD, BUT IT WAS QUICKLY FOUND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814267 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE SURGEON WAS TYING THE SUTURE. COMPLAINT PRODUCTS WERE DISCARDED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114046 ↗

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