Ti-Cron 88863086-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521059825), received between Sep 7, 2018 and Aug 23, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionAug 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VALVE REPLACEMENT PROCEDURE, THE SUTURES WERE EASILY BROKEN WHEN THEY WERE KNOTTED. THE SUTURING FAILED, SO THE SURGEON HAD TO RE-SUTURE INCREASING THE DURATION OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607145 ↗
• InjuryJul 13, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE FOR 30 MINUTES IN AN INTERMITTENT SUTURING ON THE HEART VALVE DURING A HEART VALVE REPLACEMENT, THE THREAD OF THE DEVICE BROKE. THE SUTURE SPACER FELL INTO THE PATIENT'S CAVITY. SURGICAL PROCEDURE WAS EXTENDED BY 30 MINUTES DUE TO DEVICE ISSUE. SURGEON FIND AND PROBE THE FALLEN COMPONENT TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 15002065 ↗
• MalfunctionJan 28, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN INTERMITTENT SUTURING IN AN AORTIC VALVE REPLACEMENT, THE THREAD OF THE DEVICE BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242803 ↗
• MalfunctionJan 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE NURSE OPENED THE DEVICE, WHEN ATTEMPTING TO TAKE THE NEEDLE OUT OF THE PACKAGE, THE NURSE FOUND THAT THE THREAD AND THE NEEDLE DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265597 ↗
• MalfunctionSep 7, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO AN OPEN MITRAL VALVE REPLACEMENT, A PACKAGING ISSUE WAS OBSERVED, IT TURNED OUT THAT THE OUTER PACKAGING INDICATED THAT THERE WERE 8 PIECES PER PACKAGE, HOWEVER, UPON OPENING THERE WERE 9 PIECES PER PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855152 ↗

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-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-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-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-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