FDA & Regulatory
Recalls, PMA approvals, and adverse events for heart valve devices
Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. ...
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM OPEN PIVOT MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER. THE REASON FOR THE REPLACEMENT ...
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF ...
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF ...
Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
Company: ABBOTT MEDICAL
— Applicant: ABBOTT MEDICAL
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF ...
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF ...
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM MOSAIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A COMPETITORS VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED THAT, DURING AN UL...
IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, A 505DA20 MECHANICAL HEART VALVE WAS IMPLANTED AND ABNORMAL LEAFLET OPENING AND CLOSING OF THE MECHANICAL VALVE LEAFLET WAS OBSERVED ...
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF ...
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 27MM HANCOCK II BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE WAS FOUND TO HAVE A SUTURE BREAKAGE. UPON OPENING THE VALVE COVER, THE RETA...
Company: Cardinal Health
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
Company: LifeNet
Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
Company: Abbott Medical
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact...
Company: Edwards Lifesciences, LLC
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Company: Cardinal Health 200, LLC
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Company: Cryolife Inc
Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a...
Company: Occlutech Holding AG
— Applicant: Occlutech Holding AG
Company: W. L. Gore & Associates, Inc.
— Applicant: W. L. Gore & Associates, Inc.
Company: Edwards Lifesciences, LLC
— Applicant: Edwards Lifesciences, LLC
Company: Edwards Lifesciences, LLC
— Applicant: Edwards Lifesciences, LLC
Company: Medtronic, Inc.
— Applicant: Medtronic, Inc.
Company: Edwards Lifesciences, LLC
— Applicant: Edwards Lifesciences, LLC
Company: Medtronic, Inc.
— Applicant: Medtronic, Inc.