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VISORB 496ARecalls & reported problems

C.P. Medical Corporation · Class 2

Data updated Oct 16, 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 10790986000671), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Frayed1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 13, 2019Material Frayed

    IT WAS REPORTED SIZE 4/0 PGA SUTURE BEING WEAK AND FRAYING UPON USE. (LOT# 190501-51) THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE SURGERY WASN'T DELAYED GREATER THAN 30 MINUTES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9470125 ↗

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Sources and updates

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