Coated VICRYL J587HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031041486), received between Feb 24, 2022 and Apr 29, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED AN ANIMAL UNDERWENT A STERILIZATION/REPROCESSING VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN STARTED HER MUSCULAR OVERJET, THE NEEDLE DID NOT PRICK AS IF THE NEEDLE TIP WAS DULL. SURGERY COULD BE PERFORMED USING ANOTHER THREAD FROM THE SAME BOX WITHOUT AFFECTING THE ANIMAL TO DATE. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED AT THE TIP. ONE SIDE OF THE NEEDLE WAS RECEIVED; THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE.THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE TIP OF THE NEEDLE DURING USE DUE TO TENSILE OVERLOAD. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926486 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DOG OOPHORECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE VET WAS SUTURING THE WHITE LINE. SHE HAD ALREADY PERFORMED 6 OR 7 STITCHES WITHOUT DIFFICULTY. ON RE-STITCHING THE MUSCLE WALL WITHOUT PRESSURE, THE NEEDLE BROKE CLEANLY ON THE THREAD SIDE (THE NEEDLE DIDN'T PULLED OFF, ACCORDING TO THE VET). THE NEEDLE WAS NOT TWISTED, ACCORDING TO THE VET. THE BROKEN NEEDLE TIP FELL INTO THE DOG'S ABDOMINAL CAVITY. THE VET DID NOT FIND THE NEEDLE TIP. AN ABDOMINAL X-RAY SHOWS THE NEEDLE TIP IN THE ABDOMINAL CAVITY. SURGERY WAS PERFORMED USING ANOTHER THREAD FROM THE SAME BOX FOR THE MUSCULAR PLANE. TO DATE, THE DOG IS SYMPTOM-FREE. SHE IS POTENTIALLY AWAITING A SECOND OPERATION TO RECOVER THE NEEDLE TIP IN THE ABDOMINAL CAVITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225379 ↗
• MalfunctionJan 19, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN TIGHTENED THE KNOTS FOR VASCULAR LIGATIONS THE THREAD BROKE WITHOUT EXERTING EXCESSIVE TENSION, SOMETIMES ON THE SIDE OF THE SMALL HEAD SOMETIMES ON THE SIDE OF THE BIG HEAD. IN ADDITION, THE THREAD HELD IN THE PLIERS WAS CRUMBLING. THE SURGERIES COULD BE CARRIED OUT USING OTHER THREADS FROM ANOTHER REFERENCE WITHOUT IMPACT ON THE ANIMALS TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546180 ↗
• MalfunctionJan 19, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE VETERINARIAN TIGHTENED THE KNOTS FOR VASCULAR LIGATIONS THE THREAD BROKE WITHOUT EXERTING EXCESSIVE TENSION, SOMETIMES ON THE SIDE OF THE SMALL HEAD SOMETIMES ON THE SIDE OF THE BIG HEAD. IN ADDITION, THE THREAD HELD IN THE PLIERS WAS CRUMBLING. THE SURGERIES COULD BE CARRIED OUT USING OTHER THREADS FROM ANOTHER REFERENCE WITHOUT IMPACT ON THE ANIMALS TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546179 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE WIRE HAD BROKEN DURING SURGERY. WHEN THE VETERINARIAN TIGHTENED THE KNOTS FOR VASCULAR LIGATIONS THE THREAD BROKE WITHOUT EXERTING EXCESSIVE TENSION, SOMETIMES ON THE SIDE OF THE SMALL HEAD SOMETIMES ON THE SIDE OF THE BIG HEAD. IN ADDITION, THE THREAD HELD IN THE PLIERS WAS CRUMBLING. THE SURGERY COULD BE CARRIED OUT USING OTHER THREADS FROM ANOTHER REFERENCE WITHOUT IMPACT ON THE ANIMAL TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470311 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE WIRE HAD BROKEN DURING SURGERY. WHEN THE VETERINARIAN TIGHTENED THE KNOTS FOR VASCULAR LIGATIONS THE THREAD BROKE WITHOUT EXERTING EXCESSIVE TENSION, SOMETIMES ON THE SIDE OF THE SMALL HEAD SOMETIMES ON THE SIDE OF THE BIG HEAD. IN ADDITION, THE THREAD HELD IN THE PLIERS WAS CRUMBLING. THE SURGERY COULD BE CARRIED OUT USING OTHER THREADS FROM ANOTHER REFERENCE WITHOUT IMPACT ON THE ANIMAL TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470055 ↗
• InjuryJun 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, SUCCESSIVE BREAKAGE OF 2 NEEDLES (DIFFERENT UNITS FROM THE SAME BATCH) DURING FIXATION OF THE RIGHT-SIDE ADVANCEMENT FLAP. FRAGMENTS OF THE 2 NEEDLES NOT FOUND DESPITE CAREFUL SEARCH, INTRAOPERATIVE SCOPY AND FILTRATION OF THE CONTENTS OF THE SUCTION JAR. CONTROL X-RAYS TAKEN POSTOPERATIVELY ATTESTING TO THE PRESENCE OF FRAGMENTS AT THE SURGICAL SITE. PATIENT INFORMATION, MONITORING AND PLANNED INTERVENTION PROPOSED TO THE PATIENT FOR WITHDRAWAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17087339 ↗
• InjuryJun 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, SUCCESSIVE BREAKAGE OF 2 NEEDLES (DIFFERENT UNITS FROM THE SAME BATCH) DURING FIXATION OF THE RIGHT-SIDE ADVANCEMENT FLAP. FRAGMENTS OF THE 2 NEEDLES NOT FOUND DESPITE CAREFUL SEARCH, INTRAOPERATIVE SCOPY AND FILTRATION OF THE CONTENTS OF THE SUCTION JAR. CONTROL X-RAYS TAKEN POSTOPERATIVELY ATTESTING TO THE PRESENCE OF FRAGMENTS AT THE SURGICAL SITE. PATIENT INFORMATION, MONITORING AND PLANNED INTERVENTION PROPOSED TO THE PATIENT FOR WITHDRAWAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17087325 ↗
• MalfunctionFeb 10, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE ACCOUNT REPORTED THAT THE SUTURE THEY ORDERED WAS LABELED AS HAVING A ¿CUTTING NEEDLE¿ BUT WHEN THE PACKAGE WAS OPENED FOR A PROCEDURE IT WAS NOTICED THAT THE NEEDLE ATTACHED TO THE SUTURE WAS A ¿TAPERED NEEDLE¿. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16356274 ↗
• MalfunctionFeb 10, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE ACCOUNT REPORTED THAT THE SUTURE THEY ORDERED WAS LABELED AS HAVING A ¿CUTTING NEEDLE¿ BUT WHEN THE PACKAGE WAS OPENED FOR A PROCEDURE IT WAS NOTICED THAT THE NEEDLE ATTACHED TO THE SUTURE WAS A ¿TAPERED NEEDLE¿. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16356269 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE VET TIGHTENS THE KNOT. THE THREAD BREAKS WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595553 ↗