Pump 381 Pump Set (US)
Medical device recall Z-2964-2024. 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
- 11,236 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?
Pump 381 Pump Set (US); Product Code: 1000080;
11,236 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product 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…
Every code shown here, 1,995 characters
Product 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 411855 412888 412889 412890 412891 411541 411542 412309 411730 411731 411732 411734 411851 411853 412892 412893 411543 411544 411856 411857 411858 412887 411859 412884 412885 413323 413324 413325 413326 412918 412917 412916 412914 413321 413322 412317 412318 413327 413328 412312 412316 412638 412639 412640 412642 413329 413330 412313 412314 412633 412634 412635 412636 412310 412311 413965 413966 413967 413968 413969 413970 412270 412027 412028 414267 414269 414270 414271 414272 414273 413526 413527 413528 413529 413971 413972 413973 413974 412269 412025 412032 414264 414266 414268 414265 413044 413045 413046 413520 413521 413522 413524 413525 412919 412920 412921 412922 412923 413179 413180 413181 413182 413183 413184 413185 413186 413187 413188 413047 413048 413049 413050 413051 413052 413053 413272 413274 413275 413276 413277 413278 413171 413172 413173 413174 413175 413176 413178 413159 413160 413162 413163 413164 413165 413166 413167 413168 413005 413007 413009 413010 413013 413011 413012 413562 413563…
FDA’s list runs to 202,539 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 202,539 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.