Coated VICRYL J458HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031040052), received between Aug 13, 2020 and Nov 11, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THREE SUTURES WERE BROKEN IN A ROW DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653536 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THREE SUTURES WERE BROKEN IN A ROW DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653519 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THREE SUTURES WERE BROKEN IN A ROW DURING LIGATION. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653511 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NAIL REMOVAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING WOUND CLOSURE, IT WAS NOTICED THAT THE NEEDLE TIP HAD BEEN MISSING WHEN PUTTING THE 2ND OR 3RD STITCH. ALTHOUGH THE NEEDLE TIP WAS SEARCHED, IT WAS NOT FOUND, SO CLEANING AND SUCTION WERE REPEATED. THE NURSE COMMENTED THAT THE NEEDLE TIP WAS PROBABLY ASPIRATED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121775 ↗
• MalfunctionDec 5, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD LAPAROSCOPIC TENSION-FREE REPAIR OF LEFT INGUINAL HERNIA ON (B)(6) 2020 AN THE SUTURE WAS USED. DURING SUTURING, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951833 ↗
• MalfunctionAug 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIOPLASTY SURGERY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING SUBCUTANEOUS CLOSURE, AFTER PUTTING 1 TO 2 STITCHES, THE SURGEON NOTICED THAT THERE HAD BEEN NO NEEDLE. THE NEEDLE WAS FOUND ON THE FLOOR. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10403402 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• 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