Impella CP Smart Assist Set, Canada
Medical device recall Z-2958-2024. 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
- 323 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, Canada; Product Code: 0048-0044;
323 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 0048-0044; UDI-DI: 00813502012200; Serial Numbers: 383487 383488 383489 381637 381777 381640 381639 381638 379660 379659 379661 372534 372535 386882 389812 389809 389811 389814 389813 386881 386879 386880 386943 388495 388498…
Every code shown here, 1,997 characters
Product Code: 0048-0044; UDI-DI: 00813502012200; Serial Numbers: 383487 383488 383489 381637 381777 381640 381639 381638 379660 379659 379661 372534 372535 386882 389812 389809 389811 389814 389813 386881 386879 386880 386943 388495 388498 391472 391470 391471 387330 387329 387333 387332 387331 389489 389493 389491 389490 389492 387328 388467 388465 388527 388528 388469 388470 388471 386005 386001 386008 386006 386007 386004 386170 386168 386169 386003 385999 386009 385933 385931 385921 386000 385938 385939 385940 385923 385922 386010 385935 385937 385934 390915 390914 390913 390912 392642 392643 392644 392534 392535 392537 392538 392640 392641 392536 392835 392834 392829 392828 392903 392902 392836 392837 392833 392906 392824 392831 392830 392826 392825 393083 393082 393079 393080 393081 427384 427383 427382 427381 427379 428638 428639 428640 428630 428641 428642 428631 428629 428623 428632 429793 429780 429794 429784 429786 429787 429788 430901 429789 428645 428646 429770 431699 431702 431700 431701 431695 430897 430898 430899 433880 429771 433881 431694 431696 431698 430900 430904 430903 430902 429792 429785 429782 429797 429791 429790 435973 435975 435974 435976 435149 435152 435150 435151 435148 438046 438047 438045 438040 438041 438042 438043 438044 438048 438694 445510 445509 445514 445513 445517 445511 436001 445516 436000 435999 451167 445521 445550 445557 451173 453374 453376 453368 453236 450524 451168 450521 450541 445520 445527 450520 445524 445518 445519 445526 445525 455398 455397 455394 450518 450519 450523 454032 445549 445554 453427 453425 453231 453155 453230 453158 453426 453428 453154 453153 453369 453237 453235 453375 453373 453228 453157 453156 453370 453371 453372 453229 453234 453377 453232 445555 453233 445551 445552 451165 431647 431648 453971 453572 453571 451172 451656 452098 450544 451166 451171 452082 452083 451724 451662 451657 451725 453972 453570 455396 453424 454033 454035 453967 452099 452103 451723 453966 452076 453968 452081…
FDA’s list runs to 5,896 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 5,896 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.