MONOCRYL Y398HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031059092), received between Apr 10, 2018 and Aug 25, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437821 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT ON BEHALF OF CUSTOMER, REP STATED THAT A DOCTOR WAS USING THE UNIT WHEN THE NEEDLE CAME OFF. STATED THAT WHEN THEY TRIED A NEW SUTURE FROM THE BOX, THE SAME THING HAPPENED. STATED THAT NO INJURIES WERE REPORTED. SAMPLES IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377015 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT ON BEHALF OF CUSTOMER, REP STATED THAT A DOCTOR WAS USING THE UNIT WHEN THE NEEDLE CAME OFF. STATED THAT WHEN THEY TRIED A NEW SUTURE FROM THE BOX, THE SAME THING HAPPENED. STATED THAT NO INJURIES WERE REPORTED. SAMPLES IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377010 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT ON TWO SEPARATE EVENTS WHERE THE SUTURE NEEDLE TIPS FRACTURED OFF IN THE OR. IN BOTH INSTANCES, IT APPEARS THAT THE NEEDLE TIP BROKE OFF WHILE SUTURING. IT WAS 2 DIFFERENT SURGEONS, SO THEY DON'T THINK THE CAUSE WAS TECHNIQUE. THEY HAVE THE PACKAGING FROM ONE OF THE SURGERIES. THE OTHER ONE ONLY HAVE THE NEEDLE/SUTURE. NO PACKAGING. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579445 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT ON TWO SEPARATE EVENTS WHERE THE SUTURE NEEDLE TIPS FRACTURED OFF IN THE OR. IN BOTH INSTANCES, IT APPEARS THAT THE NEEDLE TIP BROKE OFF WHILE SUTURING. IT WAS 2 DIFFERENT SURGEONS, SO THEY DON'T THINK THE CAUSE WAS TECHNIQUE. THEY HAVE THE PACKAGING FROM ONE OF THE SURGERIES. THE OTHER ONE ONLY HAVE THE NEEDLE/SUTURE. NO PACKAGING. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579444 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE NURSE MANAGER OF L&D REPORTED THAT DURING A C-SECTION, THE SURGEON NOTED THAT THE TIP OF THE NEEDLE WAS MISSING AS SHE WAS GOING TO CLOSE THE SKIN. THE SURGICAL TECH FOUND THE TIP OF THE NEEDLE ON THE MAYO STAND. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE MAIN PART OF THE NEEDLE AND THE SUTURE WILL BE RETURNED. THE TIP OF THE NEEDLE WAS ACCIDENTALLY THROWN AWAY. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184904 ↗
• MalfunctionMay 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6)2023 AND SUTURE WAS USED. THE NEEDLE SUDDENLY DETACHED FROM THE SUTURE. THEY CONTINUED TO USE FROM THE SAME BOX TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007470 ↗
• MalfunctionMay 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE SUDDENLY DETACHED FROM THE SUTURE. THEY CONTINUED TO USE FROM THE SAME BOX TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007372 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A C-SECTION THE SUTURE BROKE DURING USE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991731 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. THE SUTURE BROKE TWICE INTRAOPERATIVELY. SUTURE BROKE ONCE WHILE PASSING THROUGH UNKNOWN TISSUE AND AGAIN WHILE TYING A KNOT. ADDITIONAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953914 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE TWICE INTRAOPERATIVELY. SUTURE BROKE ONCE WHILE PASSING THROUGH UNKNOWN TISSUE AND AGAIN WHILE TYING A KNOT. ADDITIONAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953901 ↗
• MalfunctionMay 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE, ONE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877035 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877034 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHILE SUTURING UNKNOWN TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877033 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSURE OF PERITONEUM PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE ORT NOTICED THE SHARPEST END OF THE SUTURE BROKE OFF. IT WAS COLLECTED AS WELL AS THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846212 ↗
• InjuryOct 25, 2022Break

  UPON CLOSURE OF PERITONEUM, ORT NOTICED THE SHARPEST END OF THE SUTURE BROKE OFF. IT WAS COLLECTED AS WELL AS THE PACKAGE. THE CIRCULATOR CALLED THE CHARGE NURSE TO OPERATING ROOM. COLLECTED AND PACKAGED THE BROKEN SUTURE IN ENTIRETY. NO INJURY. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674373 ↗
• MalfunctionMar 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE BEFORE IT COULD EVEN BE USED. POP OFF OCCURRED AT THE SEWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865800 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSURE, IT WAS NOTED THAT THE TIP OF A SUTURE NEEDLE HAD BROKEN OFF. IT WAS TOO SMALL OF A PIECE TO USE X-RAY OR FIND IT ON WOUND EXAM. THE NURSE ESTIMATED THAT THE SIZE OF THE BROKEN TIP WAS AT LESS THAN 2 MM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076856 ↗
• MalfunctionDec 3, 2020Break; Difficult to Remove

  PATIENT HAD A CESAREAN DELIVERY (C-SECTION). AFTER CLOSURE, IT WAS NOTED THAT THE TIP OF A SUTURE NEEDLE HAD BROKEN OFF. IT WAS TOO SMALL OF A PIECE TO USE X-RAY OR FIND IT ON WOUND EXAM. THE NURSE ESTIMATES THAT THE SIZE OF THE BROKEN TIP WAS AT LESS THAN 2 MM. THE NEEDLE WAS NOT KEPT, BUT WE HAVE THE PACKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10939922 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PTN NOTICED THAT THE SUTURE SHE HAD JUST GIVEN HER HAD TWO DULL ENDS AND THE SHARP END HAD BROKEN OFF. THE PTN NOTIFIED DOCTOR AND NURSE IMMEDIATELY AND BEGAN TO LOOK FOR THE TIP OF THE SUTURE. SHORTLY AFTER THE PTN FOUND TIP OF SUTURE ON THE DRAPE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257289 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PTN NOTICED THAT THE SUTURE SHE HAD JUST GIVEN HER HAD TWO DULL ENDS AND THE SHARP END HAD BROKEN OFF. THE PTN NOTIFIED DOCTOR AND NURSE IMMEDIATELY AND BEGAN TO LOOK FOR THE TIP OF THE SUTURE. SHORTLY AFTER THE PTN FOUND TIP OF SUTURE ON THE DRAPE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257148 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT AND WAS EASILY RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252783 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT AND WAS EASILY RETRIEVED. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252780 ↗
• MalfunctionJun 11, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE, UNKNOWN LOOP, THE TIP OF THE NEEDLE BROKE OFF. THE TIP WAS RETRIEVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586520 ↗
• MalfunctionJun 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE INTO PIECES AS IT WAS USED TO SUTURE TISSUE, UNKNOWN TISSUE TYPE, UNKNOWN LOOP. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.