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.
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: 17,837 units Lot/code info: Product Code: 0048-0014; UDI-DI: 04260113630280; Serial Number: 387712 384919 384920 384921 384922 384928 385851 385854 385852 384923 385855 384924 384925 384926 384927 387211 385859 385858 387208 387207 385857 385856 387209 385860 387210 387452 387453 387213 387449 387450 387451 387205 387204 387212 387206 387448 387125 387126 387129 387130 387131 387132 387444 387446 387447 387228 387225 387224 387411 387410 387409 387408 387406 387405 387407 388384 388383 388382 388380 388379 387412 388376 388375 386046 387413 388185 387886 387885 387884 388182 388181 388180 388178 388177 388176 386405 386404 386403 386402 386401 386399 386398 386396 388337 388336 388184 388183 387583 387582 387580 387579 387578 387577 387576 387575 388334 388333 388332 388331 388330 388329 388328 388327 388689 388688 388657 388656 388655 388654 388653 388651 388687 388686 388685 388683 388862 388861 388860 388859 388858 388857 388856 388855 388326 388325 388892 388985 388984 388983 388982 388707 388706 388705 388704 388703 388702 388701 388962 388961 388960 388854 388888 388887 388885 388884 388710 388709 388708 388729 388728 388727 388726 388725 388724 388723 388722 384653 384652 388890 388959 388958 388956 388955 388954 388953 388356 388355 389079 389078 389077 389076 389075 389074 389073 389072 389071 388721 387561 387562 387560 387559 387557 387558 387555 387556 388104 388105 390083 390086 388103 388102 388101 388100 388096 388097 388098 388099 390216 390215 390214 390226 390222 390221 390220 390219 3
04260113630280
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.