Biopsy Forceps 504302Recalls & reported problems
Cordis Corporation · BIOPSY FORCEPS 5.5F STD 50CM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032056113), received between Jun 18, 2024 and Mar 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Cardiac Tamponade1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Device Contamination with Chemical or Other Material
AS REPORTED, FOREIGN MATERIAL WAS REPORTED IN THE JAW OF A 5.5F BIOPSY FORCEPS UPON OPENING. UPON INSPECTION, THE JAW DID NOT OPEN, SO THE INNER SURFACE WAS NOT ABLE TO BE EXAMINED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546190 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THERE WAS A DEATH DURING A MYOCARDIAL BIOPSY PROCEDURE WHILE USING THE 5.5F BIOPSY FORCEPS. THE PATIENT WAS AT HIGHER RISK DUE TO SAMPLING CLOSER TO THE APEX OF THE HEART, CARDIAC TAMPONADE DEVELOPED DURING SAMPLING AND THE PATIENT DIED. IT WAS REPORTED THERE WAS AN OPERATIONAL ERROR ON THE PART OF THE DOCTOR IN CHARGE. A NON-CORDIS SHEATH LISTED AS A CONCOMITANT DEVICE; HOWEVER, IT WAS REPORTED TO ¿NOT BE CLINICALLY USED¿. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: Cardiac Tamponade
MAUDE report 19562710 ↗
Other DEVICE, BIOPSY, ENDOMYOCARDIAL devices
- Jawz Endomyocardial Biopsy Forceps 190075Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial3 reports
- Cook G05389Cook Incorporated · DEVICE, BIOPSY, ENDOMYOCARDIAL3 reports
- Biopsy Forceps 504300Cordis US Corp. · DEVICE, BIOPSY, ENDOMYOCARDIAL3 reports
- Jawz Endomyocardial Biopsy Forceps 190081Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial2 reports
- Jawz Endomyocardial Biopsy Forceps 190051Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial2 reports
- Jawz Endomyocardial Biopsy Forceps 190030Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial2 reports
- Jawz Endomyocardial Biopsy Forceps 190070Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial2 reports
- Jawz Endomyocardial Biopsy Forcep 190065Argon Medical Devices, Inc. · Device, Biopsy, Endomyocardial1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.