Coated VICRYL J771DRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031042858), received between Jul 20, 2019 and Mar 30, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THERE WAS DAMAGE LIKE THE REMAINS OF A SWAGE ON THE ATTACHING NEEDLE AND SUTURE. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. 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 24717659 ↗
• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MAXILLOFACIAL SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN ORAL AND MAXILLOFACIAL SURGERY, THE NEEDLE SWAGE PART AND THE SUTURE WERE EASY TO DETACH. NO PIECES FELL INTO THE PATIENT. IT WAS A CONTROL RELEASE NEEDLE. THE REPORT THAT THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING THIS CASE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570552 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE IS NO POSSIBILITY OF PIECES LEFT INSIDE THE PATIENT. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. 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 24129960 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382232 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382229 ↗
• MalfunctionDec 5, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS SHAGGY BUT THE PRODUCT WAS USED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265916 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037631 ↗
• MalfunctionAug 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS INSERTED INTO THE TISSUE, AND THE NEEDLE TIP COMING FROM THE TISSUE WAS GRASPED WITH A NEEDLE HOLDER, AND WHEN IT WAS PULLED, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THE PRODUCT WAS USED ON SUBCUTANEOUS. SUTURE METHOD WAS INTERRUPTED SUTURE AND THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15297948 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN SOMETHING LIKE A FINE SPLIT ON THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594975 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223857 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE TIP OF NEEDLE BROKE. THE MEDICAL STAFF FOUND THE BROKEN NEEDLE TIP AND PUT THE BROKEN NEEDLES TOGETHER TO MAKE SURE THE WHOLE NEEDLE WAS INTACT. 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 13978599 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE DURING SEWING AT THE FIRST STITCH AS ATTACHED PHOTO. 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 13726050 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN EASILY DURING USE. THE SURGEON FELT THAT IT WAS BROKEN EASIER THAN NORMAL ONES. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690867 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. IT WAS FOUND THAT ONE NEEDLE TIP HAD BEEN BROKEN IN THE NEWLY DISPENSED SUTURE WHEN THE PACKAGE WAS OPENED. THIS NEEDLE COULD NOT BE USED FOR PUNCTURING. 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 12894196 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. THE BROKEN NEEDLE TIP WAS FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576646 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IS RESECTION SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163337 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048434 ↗
• MalfunctionMay 19, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT MULTIPLES HOLES IN CAVITY AND EXCESSIVE WRINKLES WERE NOTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850959 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE SURGICAL WOUND, THE NEEDLE TIP WAS BROKEN. THE NEEDLE TIP DID NOT FALL INTO THE BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815040 ↗
• MalfunctionJan 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS ROUGH, FRAYED, SHRINK AND CURLED AND WAS NOT SMOOTH. THE SURGEON REPORTED IT HAD AN UNUSUAL FEELING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11218539 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11111728 ↗
• MalfunctionAug 1, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PANCREATICODUODENECTOMY SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN ABOUT 1 MM DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851637 ↗
• MalfunctionJul 20, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON FELT THAT THE SUTURE HAD BEEN THICKER THAN USUAL AFTER THE PACKAGE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809870 ↗
• MalfunctionJul 20, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON FELT THAT THE SUTURE HAD BEEN THICKER THAN USUAL AFTER THE PACKAGE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809869 ↗
• MalfunctionJul 20, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SURGEON FELT THAT THE SUTURE HAD BEEN THICKER THAN USUAL AFTER THE PACKAGE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809868 ↗

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