Coated VICRYL J532HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031040984), received between Nov 13, 2019 and Oct 15, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WRONG NEEDLE TYPE. AT 10:45, WHEN USING SUTURE TO SUTURE THE PATIENT'S TISSUE, IT WAS FOUND THAT BOTH OF THE NEEDLES INSIDE WERE TRIANGULAR NEEDLES. A NEW SUTURE WAS IMMEDIATELY REPLACED AND THE SURGERY CONTINUED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290493 ↗
• MalfunctionOct 15, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED WRONG NEEDLE TYPE. AT 10:45, WHEN USING SUTURE TO SUTURE THE PATIENT'S TISSUE, IT WAS FOUND THAT BOTH OF THE NEEDLES'S INSIDE WERE TRIANGULAR NEEDLES. A NEW SUTURE WAS IMMEDIATELY REPLACED AND THE SURGERY CONTINUED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289744 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE DOCTOR WAS USING SUTURE TO SUTURE THE PATIENT'S UTERUS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675592 ↗
• MalfunctionOct 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SEWING THE PERINEAL INCISION IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667817 ↗
• MalfunctionDec 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925338 ↗
• MalfunctionDec 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ECTOPIC PREGNANCY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE CLOSURE OF THE ABDOMEN, THE SUTURE PULLED OFF THE NEEDLE. THE SURGERY WAS COMPLETED WITH A NEW ABSORBABLE SUTURE. THE PROCEDURE WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925321 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A A SIDE PERINEOTOMY WHICH WAS PERFORMED AT VAGINAL DELIVERY ON (B)(6) 2021 AND SUTURE WAS USED. THE CERVIX WAS EXAMINED AT THE END OF THE DELIVERY, AND NO LACERATION OF VAGINAL FORNIX WAS FOUND. THE VAGINAL FORNIX WAS SUTURED WITH ABSORBABLE SUTURES. AT THE TIME OF UNIT ROUNDS ON THE MORNING OF THE 6TH POSTOPERATIVE DAY, THE PATIENT HAD A SMALL AMOUNT OF LIGHT RED SECRETION FROM THE PERINEAL INCISION, AND ABSORBABLE SUTURE WAS OBSERVED TO BE EXPOSED, AND THE WOUND WAS SLIGHTLY RUDDY. CONSIDERING REJECTION TO THE SUTURE, CEFTRIAXONE SODIUM WAS ADDED FOR ANTI-INFECTIVE TREATMENT, KANGFUXIN LIQUID FOR ORAL USE AND EXTERNAL USE FOR PERINEAL WOUND. INFRARED IRRADIATION WAS USED TO PROMOTE WOUND HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Pocket Erosion

  MAUDE report 12882334 ↗
• MalfunctionOct 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL INCISION AND SUTURE OF PERINEUM PROCEDURE ON 10/11/2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHILE SEWING THE MUSCLE LAYER. THE NEEDLE WAS LOCATED BY ULTRASOUND AND RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748742 ↗
• MalfunctionOct 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL EPISIOTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHILE SEWING MUSCLE TISSUE. THE NEEDLE FELL INSIDE THE MUSCLE OF THE PATIENT BUT WAS LATER RETRIEVED BY B-ULTRASOUND. THE SURGERY WAS DELAYED FOR ABOUT 2-3 HOURS. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10748522 ↗
• MalfunctionNov 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384040 ↗
• MalfunctionNov 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF PULL OFF SUTURE NEEDLE HAPPENED WHEN SEWING THE SECOND LAYER OF THE UTERUS IN THE SECOND LOWER UTERINE SECTION. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314800 ↗
• MalfunctionNov 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF PULL OFF SUTURE NEEDLE HAPPENED WHEN SEWING THE SECOND LAYER OF THE UTERUS IN SECOND LOWER UTERINE SECTION. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314789 ↗

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