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Guardia G34784Recalls & reported problems

Cook Incorporated · Guardia Access Malleable Obturator · Class 2

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 00827002347847), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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

  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJul 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Patient problems: No Patient Involvement

    MAUDE report 10288959 ↗

Other CATHETER, ASSISTED REPRODUCTION devices

All CATHETER, ASSISTED REPRODUCTION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.