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GUARDIAN IPN914193Recalls & reported problems

Teleflex Incorporated · Guardian II · Class 2

Data updated Oct 18, 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 10841156101923), received between Aug 17, 2021 and Aug 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

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.

  • MalfunctionAug 17, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    AS REPORTED: THE GUARDIAN II VALVE BECAME FAULTY AND WOULDN'T ALLOW EQUIPMENT TO PASS THROUGH, HENCE DAMAGING A STENT. VALVE AND EQUIPMENT REMOVED, CAUSING A LARGER THEN EXPECTED BLOOD LOSS (300-400ML) FOR THE PROCEDURE. NO INJURY TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12334298 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

Sources and updates

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