Coated VICRYL J259HRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031038318), received between May 3, 2019 and Aug 4, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698937 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698936 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698837 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698834 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698821 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES KEEP BREAKING WHEN BEING TIED. THEY ARE BREAKING MIDPOINT ON THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698732 ↗
• MalfunctionNov 1, 2024Break; Break

  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 THE HEALTHCARE PROFESSIONAL, THAT A NEEDLE TIP THAT BROKE OFF. THE ONLY BOX (21 SUTURES)ON SITE WITH THE LOT NUMBER AFFECTED. NO PATIENT INJURIES WERE A RESULT AS THE TIPS WERE BOTH RETRIEVED. UNKNOWN IF THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591855 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR CLOSURE ON THE DEEP LAYERS. SIX WEEKS POST-OP, AT THE FOLLOW UP, THE PATIENT HAD DEVELOPED WHAT APPEARED TO BE AN INFLAMMATORY REACTION TO THE SUTURE. THE PATIENT WAS RE-OPERATED ON AND CLOSED WITH A DIFFERENT SUTURE. IT APPEARED TO BE A DELAYED HYPERSENSITIVITY REACTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 20064715 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE FELL OFF DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418505 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE FELL OFF DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418502 ↗
• InjuryJun 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPONTANEOUS VAGINAL DELIVERY ON (B)(6) 2023 AND SUTURE WAS USED FOR A VAGINAL REPAIR. DURING THE PROCEDURE, A 2ND DEGREE PERINEAL LACERATION WAS NOTED AND REPAIRED WITH SUTURE IN THE USUAL FASHION. DURING CLOSURE, THE NEEDLE PULLED FREE FROM SUTURE AND COULD NOT BE LOCATED. THE NEEDLE WAS NOT PALPATED ON PERINEAL EXAM. DUE TO LOW SUSPICION THAT NEEDLE WAS LOST IN PERINEUM, THE REMAINDER OF CLOSURE WAS PERFORMED. A PELVIC XRAY WAS ORDERED AND IT WAS CONFIRMED THAT SUTURE WAS LODGED UNDER THE SKIN. ONCE OPENED, EXPLORATION OF THE OPENED INCISION WAS PERFORMED. NOTHING WAS FELT ON THE MATERNAL RIGHT ASPECT OF THE PERINEUM. THE MATERNAL LEFT ASPECT OF THE PERINEUM WAS THEN EVALUATED AND NOTHING WAS NOTED SUPERFICIALLY. ALLIS CLAMPS WERE USED TO GRASP THE LEFT ASPECT OF THE PERINEAL TISSUE, AT THAT POINT THE NEEDLE WAS FELT AND SEEN MILDLY PROTRUDING THROUGH THE TISSUE. A KELLY WAS USED TO GRASP THE PROTRUDING PORTION AND THE DOCTOR SLOWLY PULLED OUT THE ENTIRE NEEDLE WHICH WAS NOTED TO BE INTACT. THE 2ND DEGREE LACERATION WAS AGAIN RE-APPROXIMATED/REPAIRED USING SUTURE. EXCELLENT HEMOSTASIS WAS NOTED AT THE END OF THE PROCEDURE. FINAL COUNT OF

  Patient problems: Foreign Body In Patient

  MAUDE report 17043452 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200222 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200220 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200219 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200218 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200217 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200216 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200215 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER ACCOUNT: ¿THE THREAD POPPING OFF NEEDLE.¿ NO INJURIES OR ADVERSE EVENT WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200214 ↗
• MalfunctionDec 1, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN IMPLANT PROCEDURE IN 2022 AND SUTURE WAS USED. OVER THE LAST THREE OR FOUR MONTHS DURING IMPLANT PROCEDURES THEY HAVE HAD MULTIPLE SUTURES POP OFF THE NEEDLE WHILE SUTURING UNKNOWN TISSUE DURING CLOSURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896757 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOOP RECORDER REPLACEMENT PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SUTURE WHILE CLOSING SUBCUTANEOUS TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888331 ↗
• MalfunctionOct 5, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OPERATIVE AFTER THE SURGERY, THE SUTURE BECOMES UNTIED AND THE PATIENT DEVELOPED A SUPERFICIAL INFECTION. UNKNOWN HOW THE INFECTION WAS TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 12578410 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE THE SURGEON WAS TRYING TO TIE A KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372623 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE THE SURGEON WAS TRYING TO TIE A KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372619 ↗
• MalfunctionMay 3, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WOUND CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF IN THE NEEDLE HOLDER. THE NEEDLE TIP AND NEEDLE WERE LOCATED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579224 ↗

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