Impella CP Smart Assist Set APAC
Medical device recall Z-2960-2024. Published in FDA’s Enforcement Report on Sep 11, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 11, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 705 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
705 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 0048-0047; UDI-DI: 00813502011944; Serial Numbers: 388777 388778 388780 388893 388894 384779 384780 384781 384782 384783 383447 383448 383449 384706 384705 376210 376213 376214 376215 376216 376217 376219 387222 387223 385821…
Every code shown here, 1,995 characters
Product Code: 0048-0047; UDI-DI: 00813502011944; Serial Numbers: 388777 388778 388780 388893 388894 384779 384780 384781 384782 384783 383447 383448 383449 384706 384705 376210 376213 376214 376215 376216 376217 376219 387222 387223 385821 385822 385823 385824 385825 385826 385827 385828 385829 385830 386077 386078 386079 386080 386081 386082 386083 386085 386084 386181 386182 386183 386184 386185 386186 386187 386188 386190 387467 387468 386963 386959 386960 386955 386956 386953 391935 391936 391937 391938 391940 391941 391942 391943 391944 391895 391897 391898 391899 391900 391901 391902 391904 391958 377480 377481 377482 388499 388500 388501 388502 388503 388504 391960 391959 391955 389486 389487 389488 389960 389495 389496 389498 389500 389501 389502 391957 391956 389959 389961 389963 387324 387326 392163 392164 392165 392166 392167 392169 392170 389964 389965 389967 389968 387325 387327 392162 392168 389966 388468 389527 389530 389531 389532 389533 389504 389505 389506 389507 389508 389509 389512 389513 388530 388529 388532 388531 388533 386163 386162 386161 389524 388534 389525 389526 389528 388525A 386165 389539A 386166 386167 386002A 385930A 385997A 385927 390907 390908 386164 385924 385925 385928 385929 390909 390910 390911 392393 392394 392395 392396 392397 392398 392400 392401 392533 389515 389516 389517 389518 392532 392531 392530 389514 389519 389520 389521 389522 389523 392821 392822 392823 392477 392478 392479 392481 392483 392484 392485 392486 392858 392859 392860 392861 392862 392863 392864 392865 392866 392856 392857 392808 392811 392812 392813 392816 392817 392645 392646 392648 392647 392818 392820 392867 392762 392759 391836 392761 392760 392758 391835 391837 391838 391839 391830 391833 391831 391834 392889 392888 393086 393087 393084 393085 392905 392907 392900 392898 392899 392883 392881 392886 392901 392880 392884 392885 392887 392819 392890 392896 392897 392895 392894 392893 392892 392891 393078 427408 427404 427403 427397 427395 427396…
FDA’s list runs to 12,778 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 5, 2024.
- FDA classified it on Sep 4, 2024.
- FDA’s Enforcement Report published it on Sep 11, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abiomed, Inc., of Danvers, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 12,778 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.