Impella 5.5 SmartAssist S2 Set, JP
Medical device recall Z-2970-2024. 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
- 286 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 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
286 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 1000459; UDI-DI: 00813502013054; Serial Numbers: 491248 491249 491975 491974 490744 491976 491977 490747 490725 490739 490740 490741 490742 490743 490727 491252 491239 491253 491235 491241 492012 490724 492009 491246 492005…
Every code shown here, 1,995 characters
Product Code: 1000459; UDI-DI: 00813502013054; Serial Numbers: 491248 491249 491975 491974 490744 491976 491977 490747 490725 490739 490740 490741 490742 490743 490727 491252 491239 491253 491235 491241 492012 490724 492009 491246 492005 492010 492011 491981 491240 491243 493477 491982 493476 493478 493480 493479 492004 490745 494684 494686 494687 493837 493838 493839 494689 494688 494690 494691 494692 494693 490746 494734 491236 494736 493836 494735 499143 494737 494738 491242 493840 492013 499157 499148 499156 491237 491978 494743 499153 499144 501038 501071 499155 499150 501132 499154 490728 499152 499168 501040 499738 499744 499170 501183 499740 499739 499741 501186 501041 499743 499746 501093 501205 492008 499742 501097 501094 501128 501129 501130 501184 501131 501054 491245 501204 504904 501039 501057 499147 501069 501070 501207 501213 501215 501187 498548 491238 498549 498930 501217 501072 501206 504888 491979 507422 504890 494740 504891 504893 501042 499745 499747 501056 501185 505122 507318 505123 504909 498552 498929 504913 504907 490748 494739 504879 507414 506589 504882 504883 505889 492007 504885 505890 494742 498928 501203 504905 498945 498943 498949 499145 501214 507371 507372 507315 507317 498946 506590 498550 506591 506592 498964 504884 498965 498966 498931 498973 498967 504908 498974 498975 498944 498977 506607 498950 498952 498963 498551 498553 507383 498555 498556 506606 507369 498557 504889 505121 504880 498932 498968 498554 504911 498972 506593 498969 507380 507379 498976 507418 507420 509243 501216 509247 509244 498970 505120 509246 509231 509232 509289 509245 504910 504906 509230 507373 507316 507381 509199 498971 509202 505891 509228 509288 511242 511241 509291 512372 504912 507314 511259 511260 511261 511262 512373 507416 507417 511239 511275 509163 509166 509164 512924 505892 501053 504886 512927 512928 512939 507419 498947 498948 507370 512942 512943 511240 509167 511279 511280 505119 511263 512371 511282 507382 509198 512940 512966…
FDA’s list runs to 5,227 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 5,227 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.