Abiomed, Inc.: Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

Hazard

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

Details from the source

Reason for recall: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., Unite Quantity: 2,916 units Lot/code info: Product Code: 0550-0008; UDI-DI: 00813502011531; Serial Numbers: 387019 388061 388062 388063 388064 388065 387273 388067 388068 387339 387340 387341 387342 387343 388071 388072 388073 388074 388075 388057 388058 388060 387319 387320 387321 387322 387323 383456 383457 383458 388084 383742 383731 384086 387304 387306 387307 387308 383455 383459 388081 388082 388083 388085 388076 388077 388078 388080 384031 384032 384033 384034 384035 383739 383741 383743 383729 383730 388311 388312 388301 388302 388307 383681 388605 388606 388607 388608 388286 388287 388288 388289 388295 388296 388297 388298 388299 388310 388313 388314 388290 388291 388293 388300 388304 388305 388306 388308 388309 389151 389152 388609 388624 388625 389117 389120 388619 388618 388617 388616 388615 388611 388612 388614 389116 389118 389119 389101 389102 389103 389104 389105 388626 388627 388628 388629 388630 388610 388613 389153 389154 389155 389320 389319 389318 389317 389316 389161 389163 389164 389753 389312 389306 389307 389308 389310 389162 389165 389752 389751 389160 389159 389158 389157 389156 389313 389315 389314 389309 389765 390888 387016A 389750 384800A 384618A 384811A 389744 389745 389746 389747 389748 389331 389332 389333 389334 389335 390867 390868 390869 390870 390871 389764 389766 389767 390862 390863 390864 390865 390866 389825 389826 389827 390889 390890 390891 389884 389859 389860 389861 389862 389863 389734 389735 389737 389738 389879 389880 389882 389824 389828 389877 389874 389875 389876 389

UPC codes

00813502011531

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.