FDA-Device2024-09-11Class II
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Abiomed, Inc.
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.
Sold states
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., United Kingdom.
Affected count
17,837 units
Manufactured in
24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2024Don't want to check this manually?
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