Impella 5.5 SmartAssist Set, JP
Medical device recall Z-2966-2024. 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
- 788 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 Set, JP; Product Code: 1000211;
788 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 1000211; UDI-DI: 00813502012453; Serial Numbers: 378534 379682 379683 379686 379692 379693 379694 379695 381645 381249 381250 381251 381252 369147 381644 381643 379689 381642 381259 369414 381258 381260 368474 381255 381254…
Every code shown here, 1,999 characters
Product Code: 1000211; UDI-DI: 00813502012453; Serial Numbers: 378534 379682 379683 379686 379692 379693 379694 379695 381645 381249 381250 381251 381252 369147 381644 381643 379689 381642 381259 369414 381258 381260 368474 381255 381254 379589 381257 385162 381256 379684 385163 385164 377016A 379690 385157 385158 385181 385166 385167 379591 381248 385168 385169 385174 385183 385170 385177 385535 379696 385540 368769 385666 381641 385667 385555 385644 385645 379588 385557 379685 385558 385538 385552 385178 385559 385620 385553 385554 385643 385641 386021 385171 385668 385619 381262 385671 381261 385672 385673 385674 385669 385537 385675 385688 378530 385184 385689 386037 386036 379691 386025 386126 386039 385536 386130 386136 386128 373298 386133 386134 385539 385175 386135 385159 386043 386058 386142 386060 386143 386144 386145 386147 385686 386149 385616 385670 386137 385551 386131 385542 386127 387494 387513 385617 387492 385543 387514 386023 387490 386150 385176 385541 386132 387521 387522 387520 387510 387497 387496 387509 386063 385544 386141 387515 387516 387517 385173 386064 387519 387529 387500 387501 387503 387524 386148 386022 386065 387511 387502 387824 387530 385556 404252 385642 387822 387823 387495 387534 387508 404249 404268 404248 386038A 387528 385548 387512 406345 386040 405175 405174 387523 405176 405177 405168 405169 405170 387518 404250 405171 406158 405172 404270 387527 406162 385549 387531 385179 385690 385546 387525 386140 385618 405471 405472 405464 387499 406342 405707 406168 406171 405704 404263 405705 406170 385180 386138 386129 406161 406172 387533 406159 387504 387825 405173 404271 404745 404251 406169 404284 404285 404698 404699 386057 387505 404288 404283 405466 405467 404696 404697 404304 387826 404307 404303 404286 386062 387526 404264 404267 404305 406160 404982 385165 406144A 406188 406189 406192 405858 404979 405859 405862 406173 385545 406191 405860 386059 406175 387507 404981 404266 406176 406343 404289 404290 405463A 405246…
FDA’s list runs to 14,270 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 14,270 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.