Ti-Cron 88863090-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521059924), received between Sep 28, 2017 and Mar 28, 2022 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PACEMAKER PROCEDURE, THE THREAD OF THE DEVICE SNAPPED BROKEN. BLEEDING WAS NOTED BUT NOT EQUAL TO OR MORE THAN 500CC. SUTURE WAS ABORTED AND A MANUAL HOLD WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929621 ↗
• MalfunctionMar 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PACEMAKER PROCEDURE, THE THREAD OF THE DEVICE SNAPPED BROKEN. BLEEDING WAS NOTED BUT NOT EQUAL TO OR MORE THAN 500CC. SUTURE WAS ABORTED AND A MANUAL HOLD WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928811 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO PATIENTS HAD DEEP SUTURE ABSCESSES THAT HAD PRODUCED CHRONIC FISTULAS FOLLOWING A DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP WITHIN WEEKS OF SURGERY. THE WOUNDS HAVE BEEN DRAINED FOR A YEAR, EVEN THOUGH THEY HAD WOUND CARE AND BEEN EXCISED. BOTH PATIENTS HAD INFECTIONS AND INFLAMED GRANULATION TISSUE AROUND THE SUTURES. IT WAS STATED THAT THE DEEP KNOTS OF THE SUTURE WERE THE SOURCE AND THEY HAD TWO ADDITIONAL SURGERIES. THE EVENT RESULTED TO UNANTICIPATED TISSUE LOSS AND PERMANENT TISSUE DAMAGE.

  Patient problems: Abscess; Fistula; No Code Available; Tissue Damage

  MAUDE report 9760239 ↗
• MalfunctionSep 28, 2017Break; Break

  ACCORDING TO THE REPORTER, AS PER THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900243 ↗

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-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-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-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-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-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