FDA & Regulatory
Recalls, PMA approvals, and adverse events for heart valve devices
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 ...
IT WAS REPORTED THAT 12 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATIO...
MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 21MM MOSAIC AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. TH...
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 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 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 ...
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...
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...
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 ...
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 ...