Ti-Cron 88863323-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521062535), received between Aug 1, 2018 and Sep 20, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN VALVE REPLACEMENT PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE MISSING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271216 ↗
• MalfunctionJul 25, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING HEART VALVE REPLACEMENT, THE SUTURE THREAD BROKE WHILE THE SURGEON WAS SUTURING THE VALVE USING AN INTERMITTENT SUTURING TECHNIQUE. NEW SUTURES WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223013 ↗
• MalfunctionMar 29, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A HEART VALVE SURGERY, WHEN OPENING THE PACKAGE, THERE WERE ONLY EIGHT NEEDLES AND THREADS INSTEAD OF THE NORMAL TEN. THE USER OPENED ANOTHER PACK OF SUTURES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581326 ↗
• MalfunctionJul 24, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REPLACEMENT OF STENOTIC AORTIC VALVE WITH U-SHAPED DETACHED POINT BIOPROSTHESIS SYSTEM PROCEDURE, BY THE END OF THE PROCEDURE, A SMALL PIECE OF PLEDGET WAS FOUND INSIDE THE LEFT VENTRICLE. IT WAS NOTED THAT THE PLEDGET BROKE IN HALF. ANOTHER SUTURE WAS USED WITH A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10319025 ↗
• InjuryDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN MITRAL VALVE REPAIR PROCEDURE, UPON VALVE REPLACEMENT, THE PLEDGET WAS LOST INTO PATIENT CAVITY AND SURGEON LOOKED FOR IT BUT COULD NOT FIND IT. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9519619 ↗
• MalfunctionNov 11, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE VALVE IN AN OPEN PROCEDURE, THE THREAD BROKE. A NEW DEVICE WITH THE SAME LOT NUMBER WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8058522 ↗
• MalfunctionAug 1, 2018Break

  ACCORDING TO THE REPORTER, THE SUTURE STRING BROKE WHILE TYING THE KNOT DURING VALVE REPLACEMENT. ADDITIONAL SUTURE 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 7739465 ↗

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-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-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-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-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-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