FOGARTY SOFTJAW SOFT33Recalls & reported problems
Edwards Lifesciences LLC · FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS · 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 00690103045727), received between Oct 7, 2024 and Oct 7, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE WITH THESE CLAMPS SOFT33, THE BLACK INSERTS FALL OUT OF THE VASCULAR CLAMP WITH SOME REGULARITY, THE INSERTS FALL OUT INSIDE THE PATIENTS BUT THEY WERE ABLE TO MANUALLY REMOVE THEM, WITHOUT A NEED OF AN ADDITIONAL INTERVENTION. THE TOTAL UNITS WITH THIS ISSUE WERE UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES WERE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20382768 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.