Coated VICRYL VCPP41DRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031056848), received between Jul 19, 2021 and Sep 14, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Device Markings/Labelling Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported by distributor that historically, the product has been labeled as an undyed Control Release needle suture. Two received boxes have the same product description and reference number as per current inventory; however, there are notable differences in the packaging. The new boxes contain Chinese labeling, and the suture description does not specifically indicate that the suture is undyed. Other info appears to be the same. Device availability unknown. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753095 ↗
• MalfunctionJan 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED PROCEDURE, THE NEEDLES WERE POPPING OFF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004381 ↗
• MalfunctionJan 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED PROCEDURE, THE SUTURES WERE DETACHING FROM THE NEEDLE. NO PATIENT CONSEQUENCES WERE NOTED, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004333 ↗
• MalfunctionJan 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED PROCEDURE, THE NEEDLES WERE POPPING OFF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004135 ↗
• MalfunctionJan 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNSPECIFIED PROCEDURE, THE SUTURES WERE DETACHING FROM THE NEEDLE. NO PATIENT CONSEQUENCES WERE NOTED, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004070 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE; SUTURE TIP MISSING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994784 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ABOUT 4 WEEKS AFTER THE SURGERY, BETWEEN DECEMBER AND MARCH, THE PATIENT DEVELOPED A SUTURE ABSCESS AND/OR THE WOUND OPENED UP. THE WOUND WOULD DEHISCE AND WE WOULD HAVE TO OPEN UP THE AREA WASH IT OUT IN THE OR AND RE-CLOSE. THE HCP DOES NOT KNOW IF THIS IS AN ISSUE WITH THE LOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Wound Dehiscence

  MAUDE report 21944327 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ABOUT 4 WEEKS AFTER THE SURGERY, BETWEEN (B)(6), THE HAD A WOUND DEHISCENCE AND THE PATIENT'S HIP GOT A DEEP INFECTION AND WE HAD TO EXPLANT ALL HER HARDWARE. SHE IS CURRENTLY ON ANTIBIOTICS AND WILL GET REPLANTED LATER. THE HCP DOES NOT KNOW IF THIS IS AN ISSUE WITH THE LOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21944325 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THE NURSES BROUGHT SOME SUTURE THEY FOUND THAT HAD HOLES IN THE PACKAGES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693108 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THE NURSES BROUGHT SOME SUTURE THEY FOUND THAT HAD HOLES IN THE PACKAGES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692752 ↗
• MalfunctionJul 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT ONE OF THE NURSES BROUGHT SOME SUTURE THEY FOUND THAT HAD HOLES IN THE PACKAGES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692398 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAH/BSO PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEEPS DETACHING TOO EASILY DURING CASE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941332 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAH/BSO PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEEPS DETACHING TOO EASILY DURING CASE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941331 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT PRESENTED WITH GRANULAR LESIONS ON THE VAGINAL CUFF. THE PATIENT WAS TREATED WITH A SILVER NITRATE DRESSING ON THE VAGINAL CUFF AND IT TOOK 10 WEEKS TO HEAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Granuloma; Impaired Healing; Insufficient Information

  MAUDE report 17511478 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT PRESENTED WITH GRANULAR LESIONS ON THE VAGINAL CUFF. THE PATIENT WAS TREATED WITH A SILVER NITRATE DRESSING ON THE VAGINAL CUFF AND IT TOOK 10 WEEKS TO HEAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Granuloma; Impaired Healing; Insufficient Information

  MAUDE report 17511472 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13766003 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368478 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368473 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368472 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368470 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368468 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(4) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368466 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368464 ↗
• MalfunctionAug 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF EIGHT STRANDS WHILE SUTURING THE SUBCUTANEOUS FAT LAYER. ANOTHER BOX OF THE SAME PRODUCT CODE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368461 ↗
• MalfunctionJul 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE POP OFF CAME OFF TOO EASILY. THE SUTURE AND THE NEEDLE BECOME SEPARATED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and