Impella 5.5 with SmartAssist S2 Set, EU
Medical device recall Z-2971-2024. 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
- 413 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 with SmartAssist S2 Set, EU; Product Code: 1000482;
413 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Code: 1000482; UDI-DI: 00813502013276; Serial Numbers: 495587 497107 497106 497228 497229 497232 497230 497231 497293 497295 497098 497102 497100 497101 495588 495589 498183 498185 498184 498187 498155 498927 498918 498919 498920…
Every code shown here, 1,999 characters
Product Code: 1000482; UDI-DI: 00813502013276; Serial Numbers: 495587 497107 497106 497228 497229 497232 497230 497231 497293 497295 497098 497102 497100 497101 495588 495589 498183 498185 498184 498187 498155 498927 498918 498919 498920 498921 476042A 498922 498916 498915 476040A 498914 498913 499336 498923 498924 498925 498926 499328 499329 499330 499331 499332 499308 499309 499310 499311 499312 469462A 499333 499334 499335 499509 499553 499554 499555 499556 499557 498917 500617 500616 500615 500614 500613 501467 501466 501465 501464 501463 500562 500561 500560 500559 500558 500528 477188A 500531 500527 500530 500529 500598 500597 500596 500595 500594 500603 500602 500605 500604 500606 501757 501758 501759 501760 501761 501762 501763 501764 501765 501766 499278 499279 499280 499281 499282 501754 501755 501756 501689 501692 500928 500929 500930 500931 500932 501208 501209 501211 501212 501688 499777 500311 500310 500309 500308 500307 502692 502693 503906 503907 503908 502694 502695 502696 502697 502698 503905 503923 503926 503927 503928 503849 503850 503851 503852 503853 503924 503925 503544 503547 504309 503545 503546 504310 504311 504312 504987 504313 499508 499511 503904 499776 499773 504258 504608 504606 497099 497103 497105 497104 497297 497294 497296 497326 497323 497325 498186 497327 497324 498156 498154 498157 498153 498244 498245 498243 498246 498380 504605 498379 498378 498381 498382 504819 504822 504823 504726 504727 504728 504634 504635 504636 504637 504638 504365 504364 504624 504625 504626 504627 504628 504724 505135 505136 505137 505138 504830 504831 504832 506454 506455 506435 506436 506437 506438 506439 506440 506442 506443 506456 506457 507045 507046 507047 506489 506490 506491 506492 506493 507048 507072 507073 507060 507061 507063 507050 507051 507052 507053 507069 507070 507071 507074 507075 507076 507077 507594 507595 507596 507597 507598 507641 507639 507640 507642 507643 507944 507949 507950 507951 507952 507953 507095 507096 507097 507098…
FDA’s list runs to 7,517 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 7,517 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
-
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.