FOGARTY HYDRAJAW HYDRA61Recalls & reported problems
Edwards Lifesciences LLC · FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS · Class 2
All models of FOGARTY HYDRAJAW (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Fogarty HydraJaw clamp insert, a vascular clamp component made by Edwards Lifesciences. There are 26 adverse event reports naming it, mostly describing inserts detaching or not holding properly to the clamp, yellow discoloration on the metal plate, or the product arriving contaminated or unsterile. No deaths and no injuries were reported. No recalls name this device, though reports began recently, with 22 filed in the last 12 months compared with none the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00690103044645), received between May 24, 2024 and Apr 5, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component22
- Contamination19
- Delivered as Unsterile Product4
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787062 ↗MalfunctionApr 5, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787050 ↗MalfunctionApr 5, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787041 ↗MalfunctionApr 5, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787037 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760735 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760682 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760626 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760536 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760448 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760198 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755232 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754863 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751979 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751918 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751836 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751758 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751666 ↗MalfunctionApr 1, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751606 ↗MalfunctionMar 31, 2026Contamination; Detachment of Device or Device Component
AS REPORTED, WHEN USING THIS FOGARTY HYDRAJAW CLAMP INSERT, A YELLOW DISCOLORATION WAS OBSERVED ON THE SIDE OF THE METAL PLATE OF THE DEVICE. ADDITIONALLY, IT DID NOT HOLD PROPERLY TO THE CLAMP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742586 ↗MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY HYDRAJAW CLAMP INSERT WAS LOOSE AND FELL OFF FROM THE CLAMP. AS PER CUSTOMER'S OPINION, THIS IS DANGEROUS AS THIS IS USED ON THE AORTA. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888332 ↗MalfunctionDec 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY HYDRAJAW CLAMP INSERT WAS LOOSE AND FELL OFF FROM THE CLAMP. AS PER CUSTOMER'S OPINION, THIS IS DANGEROUS AS THIS IS USED ON THE AORTA. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23860425 ↗MalfunctionDec 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY HYDRAJAW CLAMP INSERT WAS LOOSE AND FELL OFF FROM THE CLAMP. AS PER CUSTOMER'S OPINION, THIS DANGEROUS AS THIS IS USED ON THE AORTA. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23860410 ↗MalfunctionMay 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
AS REPORTED, BEFORE USE IN PATIENT, A SMALL HOLE WAS NOTICED IN THE PRIMARY PACKAGING OF THIS FOGARTY HYDRAJAW CLAMP INSERT SET. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS NOT AVAILABLE, SINCE THE PRODUCT WAS NOT USED ON ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19390366 ↗MalfunctionMay 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
AS REPORTED, BEFORE USE IN PATIENT, A SMALL HOLE WAS NOTICED IN THE PRIMARY PACKAGING OF THIS FOGARTY HYDRAJAW CLAMP INSERT SET. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS NOT AVAILABLE, SINCE THE PRODUCT WAS NOT USED ON ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19390359 ↗MalfunctionMay 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
AS REPORTED, BEFORE USE IN PATIENT, A SMALL HOLE WAS NOTICED IN THE PRIMARY PACKAGING OF THIS FOGARTY HYDRAJAW CLAMP INSERT SET. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS NOT AVAILABLE, SINCE THE PRODUCT WAS NOT USED ON ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19390348 ↗
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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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