Abiomed, Inc.: Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

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: 1,889 units Lot/code info: Product Code: 0550-0002; UDI-DI: 00813502011630; Serial Numbers: 384019 384018 384017 384016 383757 383754 383756 383755 384616 384617 384613 384609 384594 384614 384615 384610 384611 384612 384709 384623 384622 384620 384619 384793 384792 384713 384712 384711 384790 384789 384888 384887 384886 384885 384791 384884 384813 384812 384810 384809 384838 384837 384836 384835 384871 384872 384834 384870 384869 397290 397289 393811 393812 393810 393809 397288 393808 397287 397286 395384 395383 394929 395382 395381 394926 394925 394928 394927 395380 398211 398210 398208 398566 398567 398207 400356 400355 400359 400358 400357 398569 400394 400392 400391 400390 403768 403662 403661 403659 403658 403483 403481 403482 403480 403771 403770 403264 397285 397282 397281 397284 397200 397199 397198 397197 397196 397130 397294 397295 397292 397293 397291 397499 397498 397496 397309 397310 397308 397307 397306 397500 397296 398570 397305 397304 397301 397303 397302 403265 403266 403769 404032 404031 404030 404028 403886 403885 403884 403880 403879 403878 403677 403676 403675 403674 403882 403111 403114 403113 403115 403201 403202 403204 403205 403222 403223 403807 403806 403803 403805 403540 403541 403565 403543 403568 403569 403804 404008 404009 404011 404010 404194 404195 404197 406441 406440 404012 404013 406439 406438 407859 407873 407872 407871 407858 407856 407870 407869 407868 407867 407866 407329 407328 407237 407086 407085 407084 407083 407082 407874 407236 407234 407232 407233 408571

UPC codes

00813502011630

Source

Official record: FDA (Device enforcement) ↗

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