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BroadBand Loop CM-0306CNRecalls & reported problems

Riverpoint Medical, LLC · Suture · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810020081152), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2023Material Separation; Material Separation

    ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE SURGERY, THE NEEDLE OF THIS COMPLAINT PRODUCT CAME OFF FROM THE BROADBAND TAPE IMMEDIATELY WHEN THE SURGEON HOLD THE NEEDLE BY A NEEDLE HOLDER. THEREFORE, THE SURGEON USED A BACK UP OF THE SAME PRODUCT FOR THE SURGERY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16809811 ↗

Other Suture, Nonabsorbable, Synthetic, Polyethylene devices

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Sources and updates

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