Ti-Cron 88863219-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521061569), received between Dec 20, 2019 and Aug 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE USER HAD 4.5 BOXES OF SUTURES THAT WERE UNUSABLE. THE DEVICES SUPPOSED TO COME IN PACKS OF 6 BUT ALL THE ONES FROM THE LOT HAD THE WRONG QUANTITIES INSIDE THE PACKS. THE USER DID NOT USE ANY MORE OF THE AFFECTED LOT AND RE-ORDERED NEW ITEMS TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984268 ↗
• MalfunctionNov 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING BENTALL PROCEDURE, THERE WAS A SUTURE BREAKAGE. THE NURSE CHECKED THE SITUATION, BUT IT WAS UNKNOWN WHICH PRODUCT THE SUTURE WAS BROKEN WITH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760056 ↗
• MalfunctionMar 24, 2021Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR VALVE REPLACEMENT, THE NEW PLEDGETS ARE INSPECTED TO BE TOO THICK AND VERY STIFF. THE NEW PLEDGETS ARE MAKING THE VALVE NOT SIT CORRECTLY IN PATIENT. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565449 ↗
• MalfunctionMar 2, 2021Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIO VASCULAR VALVE REPLACEMENT, THE NEW PLEDGETS WERE INSPECTED TO BE TOO THICK AND VERY STIFF. THE NEW PLEDGETS WERE MAKING THE VALVE NOT SIT CORRECTLY IN PATIENT. ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398029 ↗
• MalfunctionDec 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SURGEON KNOTTED THE AORTIC VALVE FIXATION POINTS WITH TENSILE STRENGTH AND ADEQUATE HYDRATION THAT WAS USUALLY APPLIED TO THE SUTURE AND THE SUTURE PRESENTED RUPTURE. THEREFORE IT WAS NECESSARY TO MAKE A PASSAGE OF A NEW POINT WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504370 ↗

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-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-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