Carter-Thomason II Port Closure System CTI-1015PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60888937002920), received between Jan 23, 2019 and Sep 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Activation, Positioning or Separation Problem

  ASEPTIC TECHNIQUE PRESENTATION ISSUE; AFTER USING THE 'PEEL HERE' CORNER PULL, THE PAPER PEEL COVER DID NOT PEEL SMOOTHLY OFF THE PLASTIC BOWL. THE PAPER PEELED OFF IN LAYERS. THIS PREVENTED AN ASEPTIC PRESENTATION OF THE PRODUCT. OCCURRED X 2, SAME PRODUCT W/ SAME LOT #.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086330 ↗
• MalfunctionJan 23, 2019Break

  DURING CLOSURE CARTER THOMASON HANDPIECE BROKE AND BECAME USABLE. ALL PIECES ARE ATTACHED AND NO PIECES WERE SEPARATED FROM HANDPIECE. HANDPIECE TAKEN TO QUALITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270112 ↗

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, Classified
  Box 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