Ti-Cron 88863015-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521059016), received between Sep 18, 2017 and Nov 18, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K930591); 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.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1181-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING WITH A KNOT PUSHER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585242 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING WITH A KNOT PUSHER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585139 ↗
• MalfunctionMar 21, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18955143 ↗
• MalfunctionMar 21, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18953851 ↗
• MalfunctionMar 21, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18953548 ↗
• MalfunctionMar 21, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18953288 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18943312 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18943301 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18943292 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18942694 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18942599 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC/FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT/TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18942518 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18941715 ↗
• MalfunctionMar 20, 2024Product Quality Problem; Device Slipped; Human-Device Interface Problem; Product Quality Problem; Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIATOPLASTIC FUNDOPLICATION PROCEDURE, THE KNOTS OF THE TWELVE SUTURES COULD NOT EASILY SLIDE ONTO THE TISSUE, SOMETIMES THE KNOT TIE STOPPED BEFORE MAKING CONTACT WITH THE TISSUE, AND THESE STRINGS REMAINED IN THE PATIENT. THE PULLED STRINGS WERE NOT FLOATING IN THE PATIENTS CAVITY. ADDITIONALLY, THE THREAD APPEARED UNBRAIDED, MAKING IT DIFFICULT TO KNOT, AND THE STRENGTH OF THE KNOTS WAS POOR. IT TOOK A LOT MORE TIME TO SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18941571 ↗
• MalfunctionJan 30, 2024Material Frayed; Product Quality Problem; Device Slipped; Use of Device Problem; Material Frayed; Product Quality Problem; Device Slipped; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC LATERAL SUSPENSION ACCORDING TO DUBUISSION, AFTER REMOVING THE SUTURE FROM THE PACKAGING TO FIX A MESH TO THE UTERUS, IT WAS NOTICEABLE THAT THE THREAD DID NOT BEHAVE AS USUAL. THERE WAS NO DAMAGE, BUT THE THREAD WAS KINKED AND NOT ROLLED UP AS USUAL. WHEN THE SUTURE WAS USED, IT WAS GRIPPED AT THE END TO MAKE A KNOT, BUT THE THREAD WAS ALREADY UNRAVELING AT THE POINTS WHERE IT WAS GRIPPED. THE SUTURE WAS ALSO VERY DIFFICULT TO HANDLE. THE THREAD HAD POOR MOBILITY. A SECOND PACK SHOWED THE SAME KINKING OR CURLING WHEN IT WAS OPENED. THE TEST WITH A THREAD FROM ANOTHER BATCH SHOWED CLEAR DIFFERENCES. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604086 ↗
• MalfunctionSep 6, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15364844 ↗
• MalfunctionAug 1, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, ONE SUTURE PACKAGE NOTED THAT THE SUTURE BROKE WHILE SUTURING. ANOTHER DEVICE PACKAGE NOTED THAT THE SUTURE FRAYED WHILE SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 15142775 ↗
• MalfunctionSep 18, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE THE NEEDLE WAS BEING INTRODUCED IN THE TROCAR, THE THREAD BROKE. THE NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6871676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K930591. One submission often covers many models, so check the product and lot details in each record.

• Z-2827-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886326062 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i
• Z-2825-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material 8886300162 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2829-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 2 BLUE 5X18" HGS-22 non-absorbable polyester sutures Material 8886337282 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, includi
• Z-2828-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, i
• Z-2830-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, non-absorbable polyester sutures Material 8886337962 Ti-Cron is intended for use in general soft tissue approximation and/or lig
• Z-2826-2011 · Jun 3, 2011 · Terminated
  Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH non-absorbable polyester sutures Material 8886325962 Ti-Cron is intended for use in general soft tissue approximation and/or ligat