Coated VICRYL J727DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031042582), received between Nov 1, 2019 and Mar 9, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POINT BROKE OFF AND WAS UNABLE TO BE FOUND. VISUAL INSPECTION PLUS X-RAY WAS DONE. THE SURGEON DETERMINED ANY MORE DISSECTION WOULD BE DISRUPTIVE. THERE WERE NO PATIENT ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24550211 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896585 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE BROKE WHAT APPEARED TO BE IN FOUR DIFFERENT PIECES. THE PIECES WERE RETRIEVE FROM PATIENT. THE PROCEDURE WAS COMPLETED AND BELIEVES THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620799 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606596 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6)2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606594 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606593 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6)2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606560 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606556 ↗
• InjuryApr 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS REPORTED THAT THE SUTURE DID NOT HOLD, AND THE PATIENT WAS BROUGHT BACK TO FIX ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11606554 ↗
• MalfunctionNov 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT A FOREIGN SUBSTANCE LIKE A HAIR WAS IN THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9267842 ↗

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