Carter-Thomason CTI-512NRecalls & reported problems
Coopersurgical, Inc. · Carter-Thomason CloseSure System, 1 Box of 5 Systems · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60888937000094), received between Aug 12, 2024 and Nov 4, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 other recall cover devices cleared under the same FDA submission (K980123); 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Liver Laceration(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024
CLOSURE PROCEDURE KIT WITH SUTURE PASSER AND TWO GUIDES. LOT: 15942613. THE PASSER CLOSURE DEVICE BROKE IN TWO, ESSENTIALLY REDUCING CONTROL AND MAKING A SMALL CUT IN THE SURFACE OF THE LIVER. PHYSICIAN COAGULATED THE CUT WITH A SURGICAL CAUTERY UNIT TO CAUSE HEMOSTASIS. NO OTHER ISSUE OCCURRED, AND PATIENT LEFT THE SUITE WITHOUT ANY OTHER COMPLICATION.
Patient problems: Liver Laceration(s)
MAUDE report 20598179 ↗InjuryAug 12, 2024Fracture; Fracture
Recalls under the same FDA submission
These recalls involve devices cleared under K980123. One submission often covers many models, so check the product and lot details in each record.
- Z-0985-2024 · Aug 29, 2023 · Open, ClassifiedBox as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Content
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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