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: 20 units Lot/code info: Product Code: 1000361; UDI-DI: 00813502012927; Serial Numbers: 425570 425332 425331 463954 463955 476358 476357 481131 481130 481129 485279 485278 485280 480079 483437 466172A 491829 491830 491831 491832; Batch Numbers: 2024286281 2024286289 2024286292 2024375505 2024375511 2024398832 2024398833 2024413728 2024413879 2024413882 2024431078 2024431158 2024431171 2024431175 2024431650 2024431652 2024431653 2024431656 2024431673 2024431720;
00813502012927
Official record: FDA (Device enforcement) ↗
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