is it on recall

Recall archive / FDA device enforcement

Pump 381 Pump Set (US); Product Code: 1000080; — FDA record Z-2964-2024

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
Pump 381 Pump Set (US); Product Code: 1000080;
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
11,236 units
Agency-reported status
Ongoing
Source record identifier
Z-2964-2024

Open the official record

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

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityProduct Code: 1000080; UDI-DI: 00813502012279; Serial Numbers: 411717 411718 411715 411716 411720 411721 411722 411723 411724 411705 411706 411707 411711 411712 411719 411814 411813 411812 411811 411810 411809 411708 411709 411710 411713 411714 411808 411807 411806 411805 411866 411867 412111 412112 412142 412143 412110 412113 412114 412115 412116 412117 412141 412000 412148 412146 412144 412145 412140 412147 412001 412003 411860 411861 411862 411863 411864 412004 412005 411321 411477 411473 411474 411310 411890 411889 411888 411887 411475 411476 411468 411467 411469 411470 411301 411478 411461 411462 411463 411464 411465 411472 411303 411304 411309 411466 411302 411305 411306 411307 411892 411893 411894 411895 411896 412461 412463 412465 412301 412330 412331 412332 412333 412334 412335 412336 412337 412338 411891 412467 412149 412299 412300 412303 412304 412305 412308 412329 412459 412458 412460 412462 412464 412306 412307 411546 411547 411549 411550 411733 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424199A 424202A 424203A 424204A ...

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.

Related records

Medical devices recordsAbiomed, Inc. records