FDA-Device2024-09-11Class II
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
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
21 units
Manufactured in
24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2962-2024More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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