FOGARTY EVERGRIP EVERGRIP86Recalls & reported problems
Edwards Lifesciences LLC · EVERGRIP INSERT SET 86MM · Class 2
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00690103044577), received between Jul 3, 2025 and Jul 14, 2025 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 Component16
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Great Vessel Perforation1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING CLAMPING OF THE PATIENT AORTA, THIS PAIR OF EVERGRIP INSERTS DID NOT HOLD AND FELL OFF. THIS CAUSED THE CLAMPS SPIKE TO PERFORATE THE AORTIC WALL, LEADING TO PATIENT MINIMAL BLOOD LOSS. THIS AORTIC PERFORATION WAS FIXED WITH A SURGICAL SUTURE OF ABOUT 0.5X0.5 CM. THE INSERTS COULD BE RETRIEVED WITH NO NEED OF ADDITIONAL INTERVENTION. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. THE INSERTS WERE AVAILABLE FOR EVALUATION.
Patient problems: Great Vessel Perforation
MAUDE report 22493138 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 22393563 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393562 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 22393556 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393548 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393543 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393521 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393514 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393512 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393507 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393491 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393487 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393484 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393481 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT. THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393471 ↗MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS EVERGRIP86 INSERT DID NOT HOLD AND FELL OFF INSIDE THE PATIENT, THE INSERT WAS REMOVED AND REPLACED. AS PER CUSTOMER OPINION, THIS CAN BE DANGEROUS IF IT OCCURS DIRECTLY WHILE CLAMPING THE AORTA AS THIS CAN CAUSE SEVERE DAMAGE TO THE AORTA AND MAY REQUIRE REPLACEMENT. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393467 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.