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Abiomed, Inc. recalls Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Recalled September 11, 2024 · FDA recall Z-2966-2024 · Abiomed
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. · FDA Class II
Units
788 units
Sold at
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.
Description
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.
Product
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →