Abiomed, Inc.: Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

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: 413 units Lot/code info: Product Code: 1000482; UDI-DI: 00813502013276; Serial Numbers: 495587 497107 497106 497228 497229 497232 497230 497231 497293 497295 497098 497102 497100 497101 495588 495589 498183 498185 498184 498187 498155 498927 498918 498919 498920 498921 476042A 498922 498916 498915 476040A 498914 498913 499336 498923 498924 498925 498926 499328 499329 499330 499331 499332 499308 499309 499310 499311 499312 469462A 499333 499334 499335 499509 499553 499554 499555 499556 499557 498917 500617 500616 500615 500614 500613 501467 501466 501465 501464 501463 500562 500561 500560 500559 500558 500528 477188A 500531 500527 500530 500529 500598 500597 500596 500595 500594 500603 500602 500605 500604 500606 501757 501758 501759 501760 501761 501762 501763 501764 501765 501766 499278 499279 499280 499281 499282 501754 501755 501756 501689 501692 500928 500929 500930 500931 500932 501208 501209 501211 501212 501688 499777 500311 500310 500309 500308 500307 502692 502693 503906 503907 503908 502694 502695 502696 502697 502698 503905 503923 503926 503927 503928 503849 503850 503851 503852 503853 503924 503925 503544 503547 504309 503545 503546 504310 504311 504312 504987 504313 499508 499511 503904 499776 499773 504258 504608 504606 497099 497103 497105 497104 497297 497294 497296 497326 497323 497325 498186 497327 497324 498156 498154 498157 498153 498244 498245 498243 498246 498380 504605 498379 498378 498381 498382 504819 504822 504823 504726 504727 504728 504634 504635 504636 504637 504638 50436

UPC codes

00813502013276

Source

Official record: FDA (Device enforcement) ↗

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