Coated VICRYL VCP752DRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10705031055315), received between Dec 6, 2017 and Apr 6, 2026 — classified as 1 death, 8 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Separation” (44 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. 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. TOTAL 2 PRODUCTS OCCURRED BREAKAGE SUTURE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791966 ↗
• MalfunctionMar 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663416 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. IT WAS A CONTROL RELEASE NEEDLE. 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 24293843 ↗
• InjuryFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. MORE THAN 20 DAYS AFTER THE HIP REPLACEMENT SURGERY, THE WOUND OF ABSORBABLE SUTURE DEHISCED. THE DOCTOR EXCLUDED THE INFECTION AND SEWING TECHNIQUE PROBLEM, INDICATING THAT MORE THAN 20 DAYS LATER, THE ABSORBABLE SUTURE HAD POWDERED AND FAILED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24272835 ↗
• InjuryFeb 5, 2026Break; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. MORE THAN 20 DAYS AFTER THE HIP REPLACEMENT SURGERY, THE WOUND OF ABSORBABLE SUTURE DEHISCED. THE DOCTOR EXCLUDED THE INFECTION AND SEWING TECHNIQUE PROBLEM, INDICATING THAT MORE THAN 20 DAYS LATER, THE ABSORBABLE SUTURE HAD POWDERED AND FAILED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 24272642 ↗
• MalfunctionFeb 5, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCTS LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED. THERE SHOULD BE TWELVE PACKAGES OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY ELEVEN PACKAGES OF PRODUCTS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. UPON VISUAL INSPECTION OF THE RECEIVED BOX, IT WAS NOTED THAT IT CONTAINED ELEVEN FOIL PACKETS INSTEAD OF THE REQUIRED TWELVE. HOWEVER, IT COULD NOT BE DETERMINED WHETHER ONLY ELEVEN SAMPLES WERE ORIGINALLY PLACED INSIDE THE BOX. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269609 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160977 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160972 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160515 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160512 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160500 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160489 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160473 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160452 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160419 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160414 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160334 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE WAS DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160310 ↗
• MalfunctionJul 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTOCOLECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. THE DOCTOR REPORTED THAT THE NEEDLE AND SUTURE JUNCTION WOULD BREAK BUT NOT YET. CHANGED ANOTHER ONE THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586267 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: LINEA ALBA SUPPORT METHOD OF PROPHYLACTIC LOOP ILEOSTOMY VIA LOWER ABDOMINAL MIDLINE INCISION FOR RECTAL CANCER: A RETROSPECTIVE COHORT STUDY. THE AIM OF THIS STUDY IS TO EVALUATE THE CLINICAL APPLICATION VALUE AND POTENTIAL BENEFITS OF A NOVEL APPROACH NAMED LINEA ALBA SUPPORT METHOD (LASM) OF PROPHYLACTIC LOOP ILEOSTOMY VIA LOWER ABDOMINAL MIDLINE INCISION. BETWEEN (B)(6) 2021 AND (B)(6) 2023, A TOTAL OF 102 PATIENTS, 54 PATIENTS UNDERWENT TRADITIONAL METHOD OF PROPHYLACTIC LOOP ILEOSTOMY (TM GROUP) AND 48 PATIENTS UNDERWENT LINEA ALBA SUPPORT METHOD OF PROPHYLACTIC ILEOSTOMY VIA MIDLINE INCISION IN THE LOWER ABDOMEN (LASM GROUP) WERE INCLUDED IN THIS STUDY. THE MAJORITY OF THE PARTICIPANTS WERE 30 MALES FROM LASM GROUP AND 38 MALES FROM TM GROUP AND 18 FEMALES FROM LASM GROUP AND 16 FEMALES FROM TM GROUP WITH A MEAN AGE OF 59 FROM LASM GROUP AND 62.9 FROM TM GROUP. IN TRADITIONAL LOOP ILEOSTOMY PROCEDURE THE SEROMUSCULAR LAYER OF THE ILEUM AND ITS MESENTERY WERE CIRCUMFERENTIALLY SUTURED WITH THE PERITONEUM AND ANTERIOR SHEATH OF RECTUS ABDOMINIS MUSCLE USING COATED VICRYL PLUS (VCP1711D; 4¿0 ABSORBABLE SUTURE, ETHICON), WHILE IN THE LASM OF PROPHYLACTIC LOOP ILEOSTOMY TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pneumonia; Prolapse; Unspecified Infection; Urinary Retention

  MAUDE report 22060580 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT FELT THAT THE NEEDLE-SUTURES WERE EASIER TO DETACH THAN USUAL ABNORMALLY, SO SEVERAL REPLACEMENTS FROM THE SAME LOT WERE USED IN SUCCESSION, BUT THEY WERE ALL DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 21767337 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT FELT THAT THE NEEDLE-SUTURES WERE EASIER TO DETACH THAN USUAL ABNORMALLY, SO SEVERAL REPLACEMENTS FROM THE SAME LOT WERE USED IN SUCCESSION, BUT THEY WERE ALL DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 21767328 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT FELT THAT THE NEEDLE-SUTURES WERE EASIER TO DETACH THAN USUAL ABNORMALLY, SO SEVERAL REPLACEMENTS FROM THE SAME LOT WERE USED IN SUCCESSION, BUT THEY WERE ALL DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 21767298 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT FELT THAT THE NEEDLE-SUTURES WERE EASIER TO DETACH THAN USUAL ABNORMALLY, SO SEVERAL REPLACEMENTS FROM THE SAME LOT WERE USED IN SUCCESSION, BUT THEY WERE ALL DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 21767286 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT FELT THAT THE NEEDLE-SUTURES WERE EASIER TO DETACH THAN USUAL ABNORMALLY, SO SEVERAL REPLACEMENTS FROM THE SAME LOT WERE USED IN SUCCESSION, BUT THEY WERE ALL DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. 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 21767275 ↗

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