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Carter-thomason CloseSure System XL (REGARD Distributed) 733776Recalls & reported problems

Coopersurgical, Inc. · Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL. Distributed under REGARD Brand. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

  1. Aug 29, 2023Class IIOpen, Classified

    Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

    Z-0985-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Other Laparoscope, General & Plastic Surgery devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page