Coated VICRYL J741DRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031042650), received between Mar 6, 2019 and Oct 29, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Material Separation; Material Separation

  IT WAS REPORTED A UNDERWENT A CAESAREAN SECTION SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS USED ON MYOMETRIUM. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562119 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. T WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE IS WEAK AND DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 20017024 ↗
• MalfunctionAug 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE IS WEAK AND DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 20006721 ↗
• MalfunctionAug 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. T WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE IS WEAK AND DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 20003705 ↗
• MalfunctionJun 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE 06/01/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. A DIFFERENT LOT PRODUCT WAS USED WITHOUT ANY PROBLEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831442 ↗
• MalfunctionMay 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE EASIER THAN USUAL. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283183 ↗
• MalfunctionMay 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE EASIER THAN USUAL. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283179 ↗
• MalfunctionMay 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE EASIER THAN USUAL. THEY WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283164 ↗
• MalfunctionApr 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THIS HAPPENED IN TWO PACKAGES IN A ROW. THESE WERE CONTROL RELEASE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254823 ↗
• MalfunctionApr 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THIS HAPPENED IN TWO PACKAGES IN A ROW. THESE WERE CONTROL RELEASE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254797 ↗
• MalfunctionJan 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE FASCIA, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13209409 ↗
• MalfunctionJun 15, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING INTERRUPTED SUTURING ON THE UTERUS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152616 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE BODY PART WHEN THE NEEDLE PASSED FROM THE NEEDLE TIP TO THE BODY PART HELD THROUGH THE FASCIA. NO DEVICES WERE LEFT IN THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708385 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE WHEN CLOSING THE INCISION. THE TIP OF THE NEEDLE WAS NOT FOUND. A POST OP X-RAY WAS PERFORMED AND UNKNOWN IF FOREIGN OBJECTS WERE FOUND. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609184 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE DURING USE. THE TIP OF THE NEEDLE WAS NOT FOUND. A POST OP X-RAY WAS PERFORMED AND NO FOREIGN OBJECTS WERE FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609112 ↗
• MalfunctionMar 6, 2019Break; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN INTO PIECES WHEN OPENING THE PACKAGE. UPON EVALUATION OF THE RETURNED SAMPLE IT WAS FOUND THAT MULTIPLES WRINKLES AND HOLES WERE IN CAVITY OF FOIL PACKAGE. THE SUTURE HAD BEGUN THE DEGRADATION PROCESS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394912 ↗

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