Ti-Cron 88863185-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521061224), received between Mar 13, 2018 and Dec 26, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT DURING A ROBOTIC SACROCOLPOPEXY PROCEDURE, DIFFICULTY WAS ENCOUNTERED IN TYING INTRA-ABDOMINAL SUTURES. THE SUTURE MATERIAL WAS OBSERVED TO BE FRAGILE APPROXIMATELY 2 CM FROM THE NEEDLE INSERTION POINT AND FRAYED DURING SUTURE TYING. IT WAS NECESSARY TO CHANGE THE SUTURE MATERIAL TO ENSURE FIXATION OF THE PROSTHETIC DEVICE, AND SUTURE FRAGMENTS WERE REMOVED AS NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23901100 ↗
• MalfunctionMar 16, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, WHILE SUTURING ON A ROBOTIC LAPAROSCOPIC HIATAL HERNIA PROCEDURE, THE SUTURE FRAYED AND BROKE WHEN THEY PULLED IT DOWN WHILE TRYING ROBOTICALLY. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426785 ↗
• MalfunctionMar 12, 2019Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC HERNIA PROCEDURE, WHILE SUTURING WITH THE USE OF NEEDLE DRIVER, THE DEVICE BEGAN TO FRAY. SURGEON WAS ABLE TO TIE THE KNOTS BUT SUTURE KEEPS ON UNRAVELING. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414742 ↗
• MalfunctionMar 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE VALVE SUPPORT IN MITRAL VALVE REPAIR, THE DEVICE NEEDLE BROKEN MID-SHAFT. THEY THEN USED ANOTHER SUTURE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7362216 ↗
• MalfunctionMar 13, 2018Break; Detachment Of Device Component; Detachment of Device or Device Component; Break; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC NISSEN FUNDOPLICATION PROCEDURE, THE DEVICE'S THREAD BROKE OFF AND THE NEEDLE FELL OFF THE SUTURE. GRASPERS WERE USED TO RETRIEVE NEEDLE FROM THE PATIENT CAVITY. THERE WERE TWO INCIDENTS RELATED TO THE SAME SUTURE. FIRST, WHEN TYING THE SUTURE DURING THE PLICATION, THE SUTURE BROKE. THE KNOT WAS UNDONE AND THE SAME SUTURE AND NEEDLE WERE USED TO RESEW THE PLICATION. SECOND, WHEN REMOVING THE SUTURE AND NEEDLE FROM THE PATIENT, THE PA GRABBED THE SUTURE WITH A GRASPER TO REMOVE THE SUTURE AND NEEDLE. WHEN THE GRASPER WAS REMOVED FROM THE PATIENT IT WAS OBSERVED THAT THE NEEDLE HAD FALLEN OFF THE SUTURE. THE AMOUNT OF SUTURE MATERIAL WAS NOT MUCH AND WHEN SHE TRIED TO REMOVE IT, THE SUTURE SEPARATED FROM THE SWEDGE OF THE NEEDLE SENDING THE NEEDLE BACK INTO THE ABDOMINAL CAVITY. THE NEEDLE WAS THEN LOCATED VIA THE CAMERA INSIDE THE PATIENT AND THE PA GRABBED THE NEEDLE WITH GRASPERS AND REMOVED THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336478 ↗

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-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-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-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-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-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