Ti-CronRecalls & reported problems across all models
Covidien LP · 104 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Ti-Cron model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 220
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 2
We found 104 models of Ti-Cron by Covidien LP in the FDA's device registry (GUDID). Together they are named in 220 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Aug 6, 2026 — classified as 36 injuries, 184 malfunctions.
The most frequently reported specific device problem is “Break” (113 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ti-Cron recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 12 of these models · Recall details · FDA record ↗
- 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 · names 33 of these models · Recall details · FDA record ↗
Most reported Ti-Cron problems
Device problems
- Break113
- Detachment of Device or Device Component36
- Product Quality Problem24
- Unraveled Material23
- Adverse Event Without Identified Device or Use Problem20
- Device Slipped16
- Material Frayed14
- Human-Device Interface Problem13
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient31
- Insufficient Information30
- Unspecified Tissue Injury17
- Wound Dehiscence17
- No Code Available9
- No Information6
Ti-Cron models
104 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Ti-Cron 88863070-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 recalls4 reports
- Ti-Cron 88863309-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 recalls4 reports
- Ti-Cron 88863092-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 recalls0 reports
- Ti-Cron 88863185-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 recalls0 reports
- Ti-Cron 88863226-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 recalls0 reports
- Ti-Cron 88863015-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall18 reports
- Ti-Cron 88863147-83SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall4 reports
- Ti-Cron 88863047-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall2 reports
- Ti-Cron 88863088-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall2 reports
- Ti-Cron 88863271-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall2 reports
- Ti-Cron 88863186-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall1 report
- Ti-Cron 88863393-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall1 report
- Ti-Cron 88862775-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863012-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863017-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863026-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863035-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863048-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863050-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863054-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863056-89SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863059-53SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863087-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863109-43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863111-79SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863119-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863154-09SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863159-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863160-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863163-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863186-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863212-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863226-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863229-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863280-21SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863280-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863369-31SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron CD-3123KSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863090-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88862880-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Ti-Cron 88863097-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE19 reports
- Ti-Cron 88862818-89SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- Ti-Cron 88863256-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE9 reports
- Ti-Cron 88862947-53SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE9 reports
- Ti-Cron 88863323-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE7 reports
- Ti-Cron 88863093-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- Ti-Cron 88863324-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- Ti-Cron 88863086-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Ti-Cron 88863093-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Ti-Cron 88863185-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Ti-Cron 88863219-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Ti-Cron 88863271-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- Ti-Cron 88863027-79SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- Ti-Cron 88863090-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- Ti-Cron 88863113-81SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- Ti-Cron 88863256-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- Ti-Cron 88862879-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- Ti-Cron 88862862-34SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- Ti-Cron 88863257-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- Ti-Cron 88863306-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- Ti-Cron 88863385-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- Ti-Cron 88863023-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863054-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863090-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863091-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863113-71SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863147-89SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863155-81SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863218-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863235-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863259-52SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863290-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863369-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863369-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88862775-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88862815-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron VCD2031MSESUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- Ti-Cron 88863001-72SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863003-52SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863026-81SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863050-41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863065-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863127-79SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863167-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863185-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863186-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863205-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863205-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863213-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863221-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863251-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863256-61SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863258-42SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863259-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863260-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863348-51SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863356-56SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863379-62SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron 88863395-81SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- Ti-Cron X-1104SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
Recent Ti-Cron adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166048 ↗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 ↗MalfunctionJul 1, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE PHYSICIAN WAS SUTURING INSIDE THE UTERINE CAVITY, THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE BROKE. A NEW SUTURE WAS IMMEDIATELY USED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25675116 ↗MalfunctionJun 25, 2026Break
ACCORDING TO THE REPORTER, DURING A SHOULDER ARTHROSCOPY, THE SURGEON USED AN ACHILLES TENDON SUTURE TO REPAIR THE ROTATOR CUFF, BUT THE SUTURE BROKE TWICE CONSECUTIVELY. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED WITH AN ABSORBABLE SUTURE TO COMPLETE THE ROTATOR CUFF REPAIR. IT WAS NOTED THAT THE DURATION OF THE PROCEDURE INCREASED BY NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630773 ↗MalfunctionFeb 26, 2026Break
ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION AND INTERNAL FIXATION FOR A PATELLAR FRACTURE, THE SUTURE WAS BROKEN UPON OPENING THE PACKAGING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455132 ↗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 ↗MalfunctionDec 26, 2025Break; Material Frayed; Break; Material Frayed
IT WAS REPORTED THAT DURING A ROBOTIC SACROCOLPOPEXY PROCEDURE, DIFFICULTY WAS ENCOUNTERED IN TYING INTRA-ABDOMINAL SUTURES. THE SUTURE MATERIAL WAS OBSERVED TO BE FRAGILE APPROXIMATELY 2 CM FROM THE NEEDLE INSERTION POINT AND FRAYED DURING SUTURE TYING. IT WAS NECESSARY TO CHANGE THE SUTURE MATERIAL TO ENSURE FIXATION OF THE PROSTHETIC DEVICE, AND SUTURE FRAGMENTS WERE REMOVED AS NEEDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23901100 ↗MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREAD LOOSENS WITH EACH USE.
Patient problems: Insufficient Information
MAUDE report 23888440 ↗MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THREAD LOOSENS WITH EACH USE.
Patient problems: Insufficient Information
MAUDE report 23888428 ↗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 18, 2025Break; Break
IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING WITH A KNOT PUSHER. AN ADDITIONAL NEW SUTURE 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 23585242 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING WITH A KNOT PUSHER. AN ADDITIONAL NEW SUTURE 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 23585139 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page