Coated VICRYL D6432Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031026391), received between Dec 18, 2019 and Apr 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND A SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE SWAGE PART. THE LOT NUMBER IS UNKNOWN. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941684 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC NEPHRECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE NEEDLE WAS INSERTED INTO THE TISSUE. THE NEEDLE REMAINED IN THE ORGAN. SINCE THE NEEDLE WAS BURIED IN THE TISSUE, THE POSITION OF THE NEEDLE WAS CONFIRMED BY X-RAY EXAMINATION, THE TISSUE WAS INCISED WITH AN ELECTRIC KNIFE, AND THE NEEDLE WAS REMOVED. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ON (B)(6) 2019, THE PATIENT COMPLAINED OF AN UNUSUAL FEELING IN THE ABDOMEN. INSPECTION WAS DONE, THEN, IT SEEMED AN ORGAN WAS DAMAGED, AND LEAKAGE OCCURRED. THEN, REOPERATION WAS PERFORMED TO BUILD A STOMA. THE PATIENT IS IN THE HOSPITAL UNDER THE FOLLOW-UP OBSERVATION. IT WAS ALSO REPORTED THAT THIS POST-OP EVENT WAS NOT RELATED TO WHERE THE PRODUCT WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490594 ↗

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