MONOCRYL Y415HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031059115), received between May 16, 2018 and Feb 22, 2019 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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 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.

• MalfunctionFeb 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GASTRECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM SUTURE DURING TISSUE PASSAGE. THE SURGERY WAS COMPLETED WITH NEW SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362768 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A HEMICOLECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. NEEDLE SEPARATED FROM SUTURE DURING TISSUE PASSAGE. SURGERY COMPLETED AS PLANNED WITH NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169253 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SMALL INTESTINE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE SEPARATED FROM SUTURE DURING TISSUE PASSAGE. SURGERY COMPLETED AS PLANNED WITH NEW SUTURE. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169178 ↗
• MalfunctionAug 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. NEEDLE PULL-OFF DURING TISSUE PASSAGE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797338 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLITORAL HOOD REDUCTION, LABIAPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED WITH WOUND DEHISCENCE ON POST OP DAY 8. THE SUTURE WAS FOUND WITH KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. SURGEON OPINED THAT SUTURE BROKE POST OP. THE PATIENT WAS TREATED CONSERVATIVELY, EXPECTANT MANAGEMENT WITH NO CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565505 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLITORAL HOOD REDUCTION, LABIOPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED WITH WOUND DEHISCENCE ON POST OP DAY 4. THE SUTURE WAS FOUND WITH KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. SURGEON OPINED THAT SUTURE BROKE POST OP. THE PATIENT WAS TREATED CONSERVATIVELY, EXPECTANT MANAGEMENT WITH NO CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565404 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLITORAL HOOD REDUCTION, LABIOPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED WITH WOUND DEHISCENCE ON POST OP DAY 9. THE SUTURE WAS FOUND WITH KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. SURGEON OPINED THAT SUTURE BROKE POST OP. THE PATIENT WAS TREATED CONSERVATIVELY, EXPECTANT MANAGEMENT WITH NO CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565352 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLITORAL HOOD REDUCTION, LABIOPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED WITH WOUND DEHISCENCE ON POST OP DAY 6. THE SUTURE WAS FOUND WITH KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. SURGEON OPINED THAT SUTURE BROKE POST OP. THE PATIENT WAS TREATED CONSERVATIVELY, EXPECTANT MANAGEMENT WITH NO CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient; Wound Dehiscence

  MAUDE report 7565278 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLITORAL HOOD REDUCTION, LABIOPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED WITH WOUND DEHISCENCE ON POST OP DAY 14. THE SUTURE WAS FOUND WITH KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. SURGEON OPINED THAT SUTURE BROKE POST OP. THE PATIENT WAS TREATED CONSERVATIVELY, EXPECTANT MANAGEMENT WITH NO CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient; Wound Dehiscence

  MAUDE report 7565230 ↗
• InjuryMay 29, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LABIOPLASTY PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 11 DAYS POST OP THE PATIENT EXPERIENCED WOUND DEHISCENCE AND SURGEON OPINED THAT THE SUTURE POSSIBLY BROKE AS HE NOTED THAT THE KNOT REMAINED ON SURFACE ON ONE SIDE OF WOUND. THE SURGEON REPORTED THAT THE PATIENT MAY REQUIRE REVISION PROCEDURE IN 5 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7549049 ↗
• MalfunctionMay 16, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMICOLECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULL-OFF DURING TISSUE PASSAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345