Impella CP Smart Assist Set, EU
Medical device recall Z-2954-2024. 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
- 17,837 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, EU; Product Code: 0048-0014;
17,837 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 0048-0014; UDI-DI: 04260113630280; Serial Number: 387712 384919 384920 384921 384922 384928 385851 385854 385852 384923 385855 384924 384925 384926 384927 387211 385859 385858 387208 387207 385857 385856 387209 385860 387210…
Every code shown here, 1,996 characters
Product Code: 0048-0014; UDI-DI: 04260113630280; Serial Number: 387712 384919 384920 384921 384922 384928 385851 385854 385852 384923 385855 384924 384925 384926 384927 387211 385859 385858 387208 387207 385857 385856 387209 385860 387210 387452 387453 387213 387449 387450 387451 387205 387204 387212 387206 387448 387125 387126 387129 387130 387131 387132 387444 387446 387447 387228 387225 387224 387411 387410 387409 387408 387406 387405 387407 388384 388383 388382 388380 388379 387412 388376 388375 386046 387413 388185 387886 387885 387884 388182 388181 388180 388178 388177 388176 386405 386404 386403 386402 386401 386399 386398 386396 388337 388336 388184 388183 387583 387582 387580 387579 387578 387577 387576 387575 388334 388333 388332 388331 388330 388329 388328 388327 388689 388688 388657 388656 388655 388654 388653 388651 388687 388686 388685 388683 388862 388861 388860 388859 388858 388857 388856 388855 388326 388325 388892 388985 388984 388983 388982 388707 388706 388705 388704 388703 388702 388701 388962 388961 388960 388854 388888 388887 388885 388884 388710 388709 388708 388729 388728 388727 388726 388725 388724 388723 388722 384653 384652 388890 388959 388958 388956 388955 388954 388953 388356 388355 389079 389078 389077 389076 389075 389074 389073 389072 389071 388721 387561 387562 387560 387559 387557 387558 387555 387556 388104 388105 390083 390086 388103 388102 388101 388100 388096 388097 388098 388099 390216 390215 390214 390226 390222 390221 390220 390219 390218 390217 390174 389723 389722 389721 389720 389719 389718 389717 389715 389714 390082 390079 390077 390078 390212 390211 390207 390208 390209 390210 390167 390170 389418 389417 389422 389416 389421 389573 389424 389423 387385 387384 389682 389681 389680 389679 389678 389677 389676 389675 389435 389434 389433 387393 387391 387390 387389 387388 387387 387386 389571 389570 389569 389568 389567 389566 389565 389564 389345 389623 389622 389621 389620 389619 389618 389617 389616 389615 389674…
FDA’s list runs to 322,022 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 322,022 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.