VISORB 497ARecalls & reported problems
C.P. Medical Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10790986000688), received between Dec 13, 2019 and Dec 18, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Frayed1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2020Detachment of Device or Device Component
THE CUSTOMER REPORTED A NEEDLE DETACHMENT ON SIZE 3/0 PGA SUTURE WHICH HAPPENED DURING A DERMATOLOGICAL PROCEDURE (CYSTIC LESION ON SCALP).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11038488 ↗MalfunctionDec 13, 2019Material Frayed; Product Quality Problem
IT WAS REPORTED SIZE 3/0 PGA SUTURE BEING WEAK AND FRAYING UPON USE. (LOT# 190424-62) 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 9470126 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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