Abiomed, Inc.: Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

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: 286 units Lot/code info: Product Code: 1000459; UDI-DI: 00813502013054; Serial Numbers: 491248 491249 491975 491974 490744 491976 491977 490747 490725 490739 490740 490741 490742 490743 490727 491252 491239 491253 491235 491241 492012 490724 492009 491246 492005 492010 492011 491981 491240 491243 493477 491982 493476 493478 493480 493479 492004 490745 494684 494686 494687 493837 493838 493839 494689 494688 494690 494691 494692 494693 490746 494734 491236 494736 493836 494735 499143 494737 494738 491242 493840 492013 499157 499148 499156 491237 491978 494743 499153 499144 501038 501071 499155 499150 501132 499154 490728 499152 499168 501040 499738 499744 499170 501183 499740 499739 499741 501186 501041 499743 499746 501093 501205 492008 499742 501097 501094 501128 501129 501130 501184 501131 501054 491245 501204 504904 501039 501057 499147 501069 501070 501207 501213 501215 501187 498548 491238 498549 498930 501217 501072 501206 504888 491979 507422 504890 494740 504891 504893 501042 499745 499747 501056 501185 505122 507318 505123 504909 498552 498929 504913 504907 490748 494739 504879 507414 506589 504882 504883 505889 492007 504885 505890 494742 498928 501203 504905 498945 498943 498949 499145 501214 507371 507372 507315 507317 498946 506590 498550 506591 506592 498964 504884 498965 498966 498931 498973 498967 504908 498974 498975 498944 498977 506607 498950 498952 498963 498551 498553 507383 498555 498556 506606 507369 498557 504889 505121 504880 498932 498968 498554 504911 498972 506593 498969 50

UPC codes

00813502013054

Source

Official record: FDA (Device enforcement) ↗

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