141 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
FDA Recall
Terminated
·Medtronic Inc·Product code KRI·December 14, 2009
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·September 4, 2013
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·September 4, 2013
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·September 4, 2013
Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DXS·September 9, 2011
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
FDA Enforcement
Class II
·Terminated·Medtronic Perfusion Systems·June 23, 2021