Ti-Cron 88863324-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521062542), received between Aug 8, 2018 and Feb 1, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HEART AND GREAT VESSEL SURGERY, WHEN THE DEVICE WAS USED, THE SUTURE WAS ROUGH. THE DOCTOR CUT A SPACER OUT OF FELT SHEET FOR REINFORCEMENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280761 ↗
• InjuryJan 10, 2023Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A POST OPERATIVE AORTIC VALVE REPLACEMENT, THE ULTRASOUND REVIEW SHOWN MITRAL VALVE PARAVALVULAR LEAKAGE. IT WAS MENTIONED THAT THE SERRATION OUTSIDE OF THE SUTURE WAS TOO LARGE. THE PHYSICIAN REPORTED PULLING TISSUE, THE THREAD BODY FELT ROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16133462 ↗
• InjuryJan 10, 2023Product Quality Problem; Material Protrusion/Extrusion; Product Quality Problem; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, ON A MITRAL VALVE REPLACEMENT, THE SERRATION OUTSIDE THE SUTURE WAS TOO LARGE. THE SUTURE WAS ASTRINGENT, CUTTING THE VALVE RING TISSUE. FELT SPACERS WERE ADDED AS A REMEDIAL MEASURE. THE SURGICAL TIME WAS PROLONGED DUE TO THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16129737 ↗
• InjuryJan 3, 2023Product Quality Problem; Unraveled Material; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A HEART AND GREAT VESSEL SURGERY, THE SUTURE WAS ROUGH AND THE TISSUE WAS PULLED OPEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16088237 ↗
• MalfunctionNov 7, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE VULVA, THE THREAD ON THE FIRST DEVICE BROKE AND DROPPED. ON THE SECOND DEVICE, THE PACKAGING WAS STUCK AND COULD NOT BE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046295 ↗
• MalfunctionAug 8, 2018Break

  ACCORDING TO THE REPORTER, DURING AORTIC VALVE CHANGE, ON CLOSING, THE SUTURE BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7763065 ↗

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-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-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-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-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