Coated VICRYL J662HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031042070), received between Mar 31, 2022 and Oct 28, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING AN OB CASE MULTIPLE STITCHES HAD THE NEEDLE POP OFF WHILE SUTURING DURING CLOSURE. THEY HAD TO START OVER. THE CASE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692882 ↗
• MalfunctionOct 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING AN OB CASE MULTIPLE STITCHES HAD THE NEEDLE POP OFF WHILE SUTURING DURING CLOSURE. THEY HAD TO START OVER. THE CASE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692228 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ON (B)(6) 2022 SUTURE POPPED OUT ON RIGHT INCISION, REMOVED 4CMS OF SUTURE, INTACT. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 14056712 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. ON (B)(6) 2022 RETAINED SUTURE REMOVAL OCCURRED - SMALL WOUND SEPARATION, CLEANED. ON (B)(6) 2022- SMALL AREA NOT HEALED WITH DRAINAGE-CLEANSED. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14056505 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. ON (B)(6) 2022 IT WAS NOTED THAT THE RIGHT SIDE CORNER SUTURE REMOVED-POPPED THROUGH. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 14056091 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. ON (B)(6) 2021 THE PATIENT WAS SEEN WITH IRRITATED LEFT INCISION, 1.5CM SEPARATION WITH DRAINAGE, SAW THIN SUTURE, CLEANSED. ON (B)(6) 2021 BLEEDING FROM INCISION, LEFT CORNER SEPARATION, SUTURE REMOVED. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 14055526 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ON (B)(6) 2022 EDGES SLIGHTLY EVERTED, SOME STITCHES REMOVED, 2/24-INCISION HEALED. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054356 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. (B)(6) 2022 IT WAS NOTED 0.5CM SHALLOW REDNESS WITH SUTURE EXPOSED-5CM SUTURE REMOVED, (B)(6) 2022-RETURNED FOR WOUND RECHECK-2 DOTS POPPING OUT OF INCISION-PHYSICIAN COULD NOT REACH THEM. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054338 ↗
• MalfunctionMar 31, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. IT WAS NOTED THAT THE PATIENT RETURNED OVER THE PAST WEEKS WITH PROBLEMS WITH THIS SUTURE. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13968875 ↗

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