AESCULAP MB095RRecalls & reported problems
Aesculap, Inc. · FOGARTY Atraumatic Vascular Clamp, hydragrip, angled, 9 1/4", (235 mm) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964566752), received between Oct 24, 2024 and Nov 15, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (2 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
- Difficult to Open or Close2
- Mechanical Problem2
Patient problems
- Cardiovascular Dysfunction/Insufficiency2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2024Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close
EVENT 2. IT WAS REPORTED TO AESCULAP INC. THAT A FOGARTY HYDRAGRIP CLAMP ANG JAW 235MM (PART NUMBER: MB095R) WAS USED DURING A HEMI-ARCH REPLACEMENT OF ASCENDING AORTA WITH 32 MM DACRON GRAFT PROCEDURE ON (B)(6) 2024. THE FOLLOWING PROCEDURES WERE ALSO REPORTED: -AXILLARY ARTERY CUTDOWN FOR CANNULATION. -CIRCULATORY ARREST WITH ANTEGRADE CEREBRAL PERFUSION. -STERNAL REPAIR WITH ROBISCEK WEAVE. ACCORDING TO THE COMPLAINANT THE AORTIC CROSS CLAMP DID NOT CLOSE COMPLETELY TO FORM A SEAL. REPORTEDLY A SECOND CROSS CLAMP WAS USED AND HAD THE SAME RESULTS. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Cardiovascular Dysfunction/Insufficiency
MAUDE report 20698847 ↗InjuryNov 15, 2024Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close
EVENT 1 IT WAS REPORTED TO AESCULAP INC. THAT A FOGARTY HYDRAGRIP CLAMP ANG JAW 235MM (PART NUMBER: MB095R) WAS USED DURING A HEMI-ARCH REPLACEMENT OF ASCENDING AORTA WITH 32 MM DACRON GRAFT PROCEDURE ON (B)(6) 2024. THE FOLLOWING PROCEDURES WERE ALSO REPORTED: AXILLARY ARTERY CUTDOWN FOR CANNULATION CIRCULATORY ARREST WITH ANTEGRADE CEREBRAL PERFUSION STERNAL REPAIR WITH ROBISCEK WEAVE. ACCORDING TO THE COMPLAINANT THE AORTIC CROSS CLAMP DID NOT CLOSE COMPLETELY TO FORM A SEAL. REPORTEDLY A SECOND CROSS CLAMP WAS USED AND HAD THE SAME RESULTS. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Cardiovascular Dysfunction/Insufficiency
MAUDE report 20698841 ↗MalfunctionOct 24, 2024
AORTIC CROSS CLAMP DID NOT CLOSE COMPLETELY TO FORM A SEAL, USED A SECOND CROSS CLAMP WITH THE SAME RESULTS. INSTRUMENT WAS QUARANTINED AND VENDOR WAS NOTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521904 ↗
Other CLAMP, VASCULAR devices
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- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.