MONOCRYL Y523HRecalls & reported problems
Ethicon, LLC · Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031059436), received between Oct 2, 2019 and Apr 5, 2024 — classified as 5 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- Positioning Failure4
- Adverse Event Without Identified Device or Use Problem3
- Device Contaminated During Manufacture or Shipping2
Patient problems
- Wound Dehiscence7
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN MARCH 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE METAL WASHERS FOUND WITHIN THE SUTURE PACKAGING ON TWO DIFFERENT SUTURE PACKAGES. THEY OPENED THE REST OF THE BOX. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049927 ↗MalfunctionApr 5, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE METAL WASHERS FOUND WITHIN THE SUTURE PACKAGING ON TWO DIFFERENT SUTURE PACKAGES. THEY OPENED THE REST OF THE BOX. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049924 ↗MalfunctionMar 19, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER SKIN CLOSURE SUTURE IS CUT, SUTURE IS NOT STAYING TIED. THE SUTURE WAS UNRAVELING AT END KNOT OR BREAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18933484 ↗MalfunctionFeb 23, 2024Break; Positioning Failure; Break; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER SKIN CLOSURE SUTURE IS CUT, SUTURE IS NOT STAYING TIED AND WOUND IS DEHISCING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence
MAUDE report 18768674 ↗MalfunctionFeb 23, 2024Break; Positioning Failure; Break; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER SKIN CLOSURE SUTURE IS CUT, SUTURE IS NOT STAYING TIED AND WOUND IS DEHISCING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence
MAUDE report 18768668 ↗InjuryFeb 23, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER SKIN CLOSURE SUTURE IS CUT, SUTURE IS NOT STAYING TIED AND WOUND IS DEHISCING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 18768665 ↗InjuryNov 16, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE INCISION OPENED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 18150654 ↗InjuryNov 16, 2023Break; Positioning Failure; Break; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, ON (B)(6) 2023, THE PATIENT UNDERWENT RE-OPERATION AS THE INCISION SITE HAD OPENED. IT WAS REPORTED THAT THE SUTURE FAILED TO KNOT AND IT WAS UNKNOWN IF THE SUTURE IS UNRAVELING OR IF THE KNOTS ARE NOT HOLDING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 18150648 ↗InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. ONE DAY POST-OP ON (B)(6) 2023, THE PATIENT'S INCISION CAME APART ABOUT 1 INCH. THE INCISION WAS CLOSED WITH STERISTRIPS. ON (B)(6) 2023, THE INCISION WAS COMPLETELY APART. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 18150640 ↗InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED. ONE DAY POST-OP ON (B)(6) 2023, THE PATIENT'S INCISION CAME APART ABOUT 1 INCH. THE INCISION WAS CLOSED WITH STERISTRIPS. ON (B)(6) 2023, THE INCISION WAS COMPLETELY APART. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 18150633 ↗MalfunctionOct 2, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT BY SECTIONS. IT WAS STATED THAT THE INHERITANCE OPENED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9145007 ↗MalfunctionOct 2, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT BY SECTIONS. IT WAS STATED THAT THE INHERITANCE OPENED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9145006 ↗
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, ClassifiedMONOCRYL" (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, ClassifiedMONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345
Other SUTURE, ABSORBABLE, SYNTHETIC devices
- MONOCRYL Y426HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC141 reports
- MONOCRYL Y936HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall66 reports
- MONOCRYL Y923HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC111 reports
- MONOCRYL Y427HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall53 reports
- MONOCRYL Y496GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC86 reports
- MONOCRYL Y943GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC77 reports
- MONOCRYL Y416HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall13 reports
- MONOCRYL Y935HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.