Ti-Cron 88863256-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521061897), received between Jun 2, 2017 and Jul 6, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Detachment of Device or Device Component; No Apparent Adverse Event

  ACCORDING TO THE REPORTER DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN ON UTERINE STUMP SUSPENSION, THE THREAD BROKE ON THE FINAL KNOT. A NEW THREAD WAS USED TO SUTURE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25727204 ↗
• MalfunctionJul 6, 2026Break

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THREAD BREAKAGE OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 25726443 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC SURGERY, THE NEEDLE AND THREAD WERE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379059 ↗
• MalfunctionSep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INCISION/WOUND CLOSURE PROCEDURE, AN ATTEMPT WAS MADE TO CLOSE IT USING SUTURES, BUT THE SUTURE THREADS BROKE FOUR TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239520 ↗
• MalfunctionSep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INCISION/WOUND CLOSURE PROCEDURE, AN ATTEMPT WAS MADE TO CLOSE IT USING SUTURES, BUT THE SUTURE THREADS BROKE FOUR TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239486 ↗
• MalfunctionSep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INCISION/WOUND CLOSURE PROCEDURE, AN ATTEMPT WAS MADE TO CLOSE IT USING SUTURES, BUT THE SUTURE THREADS BROKE FOUR TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239308 ↗
• MalfunctionSep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INCISION/WOUND CLOSURE PROCEDURE, AN ATTEMPT WAS MADE TO CLOSE IT USING SUTURES, BUT THE SUTURE THREADS BROKE FOUR TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239132 ↗
• MalfunctionMay 26, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING FIRST STITCH OF REPAIR OF ESOPHAGEAL HIATUS HERNIA, WHILE FIXING THE MESH, WHEN THE NEEDLE FOR THE FIRST STITCH WAS HELD OVER THE MESH AND DIAPHRAGM AND PULLED, THOUGH THERE WAS NO PARTICULAR TENSION BEING APPLIED, THE THREAD BROKE. AS THE NEEDLE WAS BEING HELD, IT DIDN'T FALL INTO THE PATIENT'S BODY, AND THERE WAS NO IMPACT ON THE PATIENT. THE REMAINING THREAD WAS LIGATED AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086104 ↗
• InjuryJun 2, 2017Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: A HAND EXTENSOR TENORRHAPHY WAS PERFORMED. APPROXIMATELY 2 MONTHS AND 1 WEEK POST OP THE PATIENT HAD PROMINICENCE OF THE SUTURE. THE CUSTOMER CLAIMS THAT THE ADVERSE EVENT HAPPENED AFTER TENORRHAPHY OF HAND EXTENSORS. AFTER MONTH OR TWO, THE SUTURE (THE KNOT OF THE SUTURE) HAS BEEN OBSERVED TO SPIT OUT OF DERMIS. THERE WAS GRANULOMA FORMATION AT THE KNOT SITE. THE SUTURE WAS ROUTINELY HYDRATED BY POOLING THROUGH THE PHYSIOLOGICAL SOLUTION. FOR SUTURING THE HAND TENDON EXTENSOR, THEY USED KESSLER AND/OR KRAKOW SUTURING, PULLING THE SUTURE SEVERAL TIMES THROUGH THE TENDON. REMOVAL OF THE SPITTED SUTURES WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS UNANTICIPATED TISSUE LOSS DUE TO THE REMOVAL OF THE SPITTED SUTURE. THERE WAS TISSUE DAMAGE AS A RESULT OF THE PROBLEM. THE DAMAGE WAS NOT PERMANENT AFTER THE SECOND PROCEDURE. THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. IT LED TO ADDITIONAL HOSPITAL STAY . THE CURRENT PATIENT STATUS IS OK. PATIENT MEDICAL HISTORY: HEALTHY.

  Patient problems: Granuloma; No Code Available; Tissue Breakdown; Tissue Damage

  MAUDE report 6608445 ↗

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-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-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-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-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