Recall archive / FDA device enforcement

Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; — FDA record Z-2965-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Reason: 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.
Classification: Class II
Recalling firm: Abiomed, Inc.
Quantity: 11,576 units
Agency-reported status: Ongoing
Source record identifier: Z-2965-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Product Code: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 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Label field

Details supplied by the agency

Lot, code or applicability

Product Code: 1000100; UDI-DI: 00813502012828; Serial Numbers: 417756 417055 417820 417817 417818 416967 416968 417054 417056 417057 417058 417819 417821 417042 416991 417043 417024 417025 417026 417027 417028 417234 417235 417236 416989 416990 416992 416993 417040 417041 416864 416865 416866 416867 416962 416959 416887 416888 416963 417237 417238 416897 416869 416872 416873 416886 416961 416960 417833 416870 416871 416855 416854 416858 417244 417246 417245 416884 416885 417061 417062 417063 417815 417269 417270 417271 417272 417785 417786 417768 417769 417770 417771 417239 417240 417242 417243 417060 417247 417808 417809 417811 417814 417273 417782 417783 417784 417937 417938 417939 417940 417941 417498 417264 417265 417266 417267 417268 417955 417956 417494 417495 417465 417466 417467 418015 418018 418019 417816 417952 417953 417954 417497 417464 418016 418017 418732 418733 418715 418716 418717 418718 417496 418700 418701 418702 416859 416860 416861 416862 416863 418729 418730 417249 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440706 440857 440...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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., United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 11, 2024
Recall initiation date: Aug 5, 2024
Center classification date: Sep 4, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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