Ti-Cron 88863070-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521059573), received between Feb 6, 2020 and Mar 31, 2020 — classified as 1 injury, 3 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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 21, 2023Class IIOpen, Classified

   Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

   Z-0845-2024 · Root cause: Process control · Recall details · FDA record ↗

2. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ANNULOPLASTY MITRAL PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 9902026 ↗
• MalfunctionMar 24, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING THE KNOT DURING AN OPEN REPLACEMENT OF THE TRICUSPID VALVE, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9872396 ↗
• MalfunctionMar 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MITRAL ANNULOPLASTY PROCEDURE, THE SUTURE THREAD BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817467 ↗
• InjuryFeb 6, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN SUTURE WAS USED FOR EXPOSITION DURING AN AORTIC VALVE REPLACEMENT, THE THREAD BROKE. IT WAS STATED THAT THE PROCEDURE WAS PROLONGED UNDER EXTRACORPOREAL CIRCULATION AND ISCHEMIA RISK INCREASED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 9679324 ↗

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-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-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-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