V. Mueller CV1161Recalls & reported problems
Steris Corporation · COSGROVE FLEX CLAMP QUICK BEND 61 MM FOGARTY-TYPE JAW · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403036286), received between Mar 5, 2021 and Nov 30, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE HANDLE TO THEIR COSGROVE FLEX CLAMP BROKE. USER FACILITY PERSONNEL UTILIZED ANOTHER CLAMP FOR THE REMAINDER OF THE PROCEDURE. AFTER SOME PERIOD OF TIME POST-PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPIRED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18241947 ↗MalfunctionOct 12, 2023Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE CABLE ON THEIR COSGROVE FLEX CLAMP BROKE. THE COMPONENTS WERE IMMEDIATELY RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT RECEIVED AN X-RAY WHICH CONFIRMED THAT ALL COMPONENTS HAD BEEN REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17926747 ↗MalfunctionJan 5, 2022Break; Break
FLEXIBLE AORTIC VASCULAR CLAMP WAS USED TO CROSS CLAMP THE AORTA AND ARREST THE HEART DURING A CARDIOPULMONARY BYPASS PROCEDURE BROKE INTO MULTIPLE PIECES WHILE IT WAS IN SITU. SURGEON AND THE SCRUB NURSE WERE ABLE TO RETRIEVE ALL THE VISIBLE PARTS AND HANDED OVER TO THE CIRCULATING NURSE. NO PATIENT INJURY OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169855 ↗MalfunctionMar 5, 2021Break; Break
THE ARTICULATING PORTION BROKE AND THE LINKS BECAME SEPARATED FOR THREE COSGROVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423844 ↗MalfunctionMar 5, 2021Break; Break
THE ARTICULATING PORTION BROKE AND THE LINKS BECAME SEPARATED FOR THREE COSGROVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423614 ↗MalfunctionMar 5, 2021Break; Break
THE ARTICULATING PORTION BROKE AND THE LINKS BECAME SEPARATED FOR THREE COSGROVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423325 ↗
Other CLAMP, VASCULAR devices
- Heartstring III System 3.8MM HSK-3038Maquet Cardiovascular LLC · Clamp, Vascular1 recall4 deaths809 reports
- 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.