Ti-Cron 88863091-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521059979), received between Jul 21, 2017 and Jul 25, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING THE AORTIC VALVE REPLACEMENT, THE SURGEON OBSERVED HAIRS ON THE EXTENSION OF THE WIRE AND IT ALSO DEPRESSED WHEN OPENED FOR USE. MORE THAN ONE DEVICE WAS INVOLVED AND THE ISSUE OCCURRED IN SAME CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6740190 ↗
• MalfunctionJul 21, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING THE AORTIC VALVE REPLACEMENT, THE SURGEON OBSERVED HAIRS ON THE EXTENSION OF THE WIRE AND IT ALSO DEPRESSED WHEN OPENED FOR USE. MORE THAN ONE DEVICE WAS INVOLVED AND THE ISSUE OCCURRED IN SAME CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733910 ↗

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-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
• 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-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-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-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