Ti-Cron 88863309-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521062481), received between Nov 13, 2025 and Dec 19, 2025 — classified as 4 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.

• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A FIXATION OF A PACEMAKER PROBE, DURING KNOTTING, THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE FROM THE SAME LOT ALSO BROKE DURING USE. A NEW SUTURE FROM ANOTHER LOT WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847359 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A FIXATION OF A PACEMAKER PROBE, DURING KNOTTING, THE SUTURE BROKE IN THE MIDDLE. A SECOND SUTURE FROM THE SAME LOT ALSO BROKE DURING USE. A NEW SUTURE FROM ANOTHER LOT WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847355 ↗
• MalfunctionNov 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOLOGICAL INTERVENTION, DURING PULMONARY VEIN ISOLATION, WHEN CLOSING THE PUNCTURE SITE, THE TWO SUTURES WERE BROKEN IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587120 ↗
• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOLOGICAL INTERVENTION, DURING PULMONARY VEIN ISOLATION, WHEN CLOSING THE PUNCTURE SITE, THE TWO SUTURES WERE BROKEN IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543999 ↗

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-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-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-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