Coated VICRYL J327HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031038837), received between May 21, 2024 and May 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY SURGERY, ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE DOCTOR COMMENTED THAT THE SUTURE WAS EASILY BROKEN. 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 25136674 ↗
• MalfunctionSep 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED. IT WAS REPORTED THAT SUTURE DID NOT MEET CUSTOMER EXCEPTIONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130451 ↗
• MalfunctionJun 18, 2024Break; Break

  PER USER FACILITY MEDWATCH FORM, #MW (B)(4) . IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER IMPANT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING PACEMAKER IMPLANT WITH POCKET CLOSURE PROCEDURE, PHYSICIAN USED SUTURE OUT OF A PACEMAKER PACK TO CLOSE A PACEMAKER POCKET. NEEDLE DRIVER WAS USED TO PUSH THE NEEDLE THROUGH THE SKIN AND SUTURE NEEDLE BROKE IN HALF. THE NEEDLE WAS STUCK IN PATIENT'S POCKET BUT QUICKLY REMOVED BY THE PHYSICIAN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562335 ↗
• MalfunctionMay 21, 2024

  PHYSICIAN USED 3-0 STRATAFIX SUTURE OUT OF A PACEMAKER PACK TO CLOSE A PACEMAKER POCKET. NEEDLE DRIVER WAS USED TO PUSH THE NEEDLE THROUGH THE SKIN AND SUTURE NEEDLE BROKE IN HALF. THE NEEDLE WAS STUCK IN PATIENT'S POCKET BUT QUICKLY REMOVED BY THE PHYSICIAN. MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID, COATED VICRYL (PER SITE REPORTER). WORKING WITH US.

  Patient problems: Insufficient Information

  MAUDE report 19358043 ↗

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