FOGARTY HYDRAJAW HYDRA86Recalls & reported problems
Edwards Lifesciences LLC · FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00690103044652), received between Jul 12, 2024 and Sep 16, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).
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 Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793472 ↗MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING PROCEDURE, THESE PAIR OF FOGARTY HYDRAJAW INSERTS DETACHED FROM THE CLAMP AND FELL INTO THE PATIENT'S CAVITY (MANUFACTURER'S REFERENCE: (B)(4). THE SAME ISSUE OCCURRED WITH THE REPLACEMENT PAIR (MANUFACTURER'S REFERENCE: (B)(4). THERE WERE NO PATIENT INJURY OR CONSEQUENCES, AND NO ADDITIONAL IMAGING OR INTERVENTION WAS REQUIRED TO RETRIEVE THE INSERTS. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035773 ↗MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING PROCEDURE, THESE PAIR OF FOGARTY HYDRAJAW INSERTS DETACHED FROM THE CLAMP AND FELL INTO THE PATIENT'S CAVITY (MANUFACTURER'S REFERENCE: (B)(4). THE SAME ISSUE OCCURRED WITH THE REPLACEMENT PAIR (MANUFACTURER'S REFERENCE: (B)(4). THERE WERE NO PATIENT INJURY OR CONSEQUENCES, AND NO ADDITIONAL IMAGING OR INTERVENTION WAS REQUIRED TO RETRIEVE THE INSERTS. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035602 ↗MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE OF THE HYDRAJAW CLAMP INSERT, IT BECAME DETACHED FROM THE STERILIZED CLAMP AND FELL INTO THE SURGICAL FIELD. THE INSERT WAS RETRIEVED IMMEDIATELY, AND NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577999 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE HYDRAJAW CLAMP THERE WAS A GAP BETWEEN THE CLAMP AND HYDRAJAW SIDE OF THE INSERT SINCE THE HYDRAJAW WAS BENT. WHEN THE TISSUE COMES INTO CONTACT WITH THIS GAP, HYDRAJAW SIDE OF A HYDRAJAW CLAMP INSERT GOT DETACHED AND FELL INTO THE SURGICAL FIELD. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICES IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341475 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE OF THE HYDRAJAW CLAMP THERE WAS A GAP BETWEEN THE CLAMP AND HYDRAJAW SIDE OF THE INSERT SINCE THE HYDRAJAW WAS BENT. THIS HYDRAJAW CLAMP INSERT EASILY GOT DETACHED FROM THE CLAMP. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22290018 ↗MalfunctionJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THESE HYDRAJAW CLAMP INSERTS WERE FALLING OFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE INSERTS WERE NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19728061 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.