FOGARTY HYDRAJAWRecalls & reported problems across all models
Edwards Lifesciences LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of FOGARTY HYDRAJAW by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between May 24, 2024 and Sep 16, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FOGARTY HYDRAJAW problems
Device problems
- Detachment of Device or Device Component29
- Contamination19
- Delivered as Unsterile Product4
Patient problems
- No Clinical Signs, Symptoms or Conditions33
FOGARTY HYDRAJAW models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FOGARTY HYDRAJAW HYDRA61CLAMP, VASCULAR26 reports
- FOGARTY HYDRAJAW HYDRA86CLAMP, VASCULAR7 reports
Recent FOGARTY HYDRAJAW adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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