Coated VICRYL VCP917HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031056039), received between Oct 28, 2018 and Apr 13, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT DELIVERED SPONTANEOUSLY ON (B)(6) 2020 AND SUTURE WAS USED TO SUTURE TORN RIGHT LABIA MAJORA. THE PATIENT EXPERIENCED POOR WOUND HEALING. ONE MONTH LATER, ABOUT 1.5 CM ABSCESS APPEARED AT THE SUTURE SITE, AND MULTIPLE DEBRIDEMENT WAS PERFORMED; REPEATED ONE WEEK LATER AND TWO WEEKS LATER, AND WOUND HAS NOT HEALED YET.

  Patient problems: Abscess; Impaired Healing; Post Operative Wound Infection

  MAUDE report 14103144 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT WENT TO THE HOSPITAL AND COMPLAINED OF PAIN. AFTER CHECK, THE WOUND WAS FOUND SPLIT AND THE NURSE TREATED THE WOUND ACCORDINGLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 8203706 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT WENT TO THE HOSPITAL AND COMPLAINED OF PAIN. AFTER CHECK, THE NURSE FOUND THE WOUND SPLIT AND TREATED THE WOUND IN NORMAL PROCESS ACCORDINGLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 8203662 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT RETURNED TO THE HOSPITAL AND COMPLAINED OF PAIN. AFTER CHECK, THE NURSE CUT OFF THE SUTURE AND TREATED THE PATIENT¿S WOUND IN NORMAL PROCESS ACCORDINGLY. IT WAS REPORTED THAT THE NURSE CLAIMED THE SUTURE WAS NOT ABSORBED WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8203626 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT CAME TO THE HOSPITAL AND COMPLAINED OF PAIN. AFTER CHECK, THE NURSE CUT OFF THE SUTURE AND TREATED THE WOUND IN NORMAL PROCESS ACCORDINGLY. IT WAS REPORTED THAT THE NURSE CLAIMED THE SUTURE WAS NOT ABSORBED WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8203620 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT WENT TO HOSPITAL AND COMPLAINED OF PAIN. AFTER CHECK, THE NURSE CUT OFF THE SUTURE AND TREATED THE WOUND IN NORMAL PROCESS ACCORDINGLY. IT WAS REPORTED THAT THE NURSE CLAIMED THE SUTURE WAS NOT ABSORBED WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8203619 ↗
• InjuryOct 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. THE HEALTHCARE PROFESSIONAL OPINED THE SUTURE DID NOT ABSORB WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain

  MAUDE report 8011131 ↗
• InjuryOct 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED ON PERINEAL NOTCH. ON (B)(6) 2018, THE PATIENT¿S WOUND SPLIT FULLY AND THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. THE HEALTHCARE PROFESSIONAL OPINED THE SUTURE DID NOT ABSORB WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain; Wound Dehiscence

  MAUDE report 8011129 ↗
• InjuryOct 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. THE HEALTHCARE PROFESSIONAL OPINED THE SUTURE DID NOT ABSORB WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain

  MAUDE report 8011128 ↗
• InjuryOct 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. THE HEALTHCARE PROFESSIONAL OPINED THE SUTURE DID NOT ABSORB WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain

  MAUDE report 8011126 ↗
• InjuryOct 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED FOR PERINEAL II LACERATION. ON (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. THE HEALTHCARE PROFESSIONAL OPINED THE SUTURE DID NOT ABSORB WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain

  MAUDE report 8011125 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PHYSIOLOGICAL DELIVERY ON (B)(6) 2018 AND SUTURE WAS USED ON PERINEAL II LACERATION. ON (B)(6) 2018, THE PATIENT¿S WOUND SPLIT FULLY AND THE PATIENT COMPLAINED OF PAIN. THE PATIENT¿S SYMPTOMS WERE RELIEVED AFTER SUTURE REMOVAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Pain; Wound Dehiscence

  MAUDE report 8011122 ↗

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