Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s…
Medical device recall Z-1590-2023. Published in FDA’s Enforcement Report on May 24, 2023.
- FDA Class I
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 May 24, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 610 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
610 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Impella 5.5 JP(1000211) Serial Numbers: 368476 375832 379587 379685 381256 381255 381642 385162 385180 385179 385641 385666 385671 385674 386036 386037 386045 386058 386128 386133 386134 386132 386138 386143 386149 386147 387492 387498…
Every code shown here, 2,000 characters
Impella 5.5 JP(1000211) Serial Numbers: 368476 375832 379587 379685 381256 381255 381642 385162 385180 385179 385641 385666 385671 385674 386036 386037 386045 386058 386128 386133 386134 386132 386138 386143 386149 386147 387492 387498 385548 385546 385549 387509 387506 404248 404251 387526 404272 387502 387501 387503 387518 387515 387532 387825 405172 405171 405170 405175 405173 405176 405177 406161 406342 404263 406171 406170 405464 405472 405471 405704 404267 404266 404285 404283 404307 404696 404698 404699 404745 405246 405860 405859 405862 405968A 406175 406173 404292 406176 Impella 5.5 Smart Assist (0550-0002) Serial Numbers: 321271 333003 333035 333043 334696 345239 360280 360511 365273 365274 367019 367021 370130 370129 375223 375221 375671 381808 381809 384612 384834 397290 394926 395381 398208 398567 403771 403886 403884 404028 397198 397200 397284 397281 397295 397294 397291 397309 397307 397310 397306 397499 397496 397500 397498 403114 407858 407868 407873 407872 407234 408363 408365 408572 411385 411444 412012 412360 412359 413091 413092 413643 413930 413931 416785 406330 406329 406331 405433 405435 405434 404452 405714 405715 404938 404940 406378 406381 405946 405947 405469 405603 405607 405710 405709 404746 404812 404808 404915 404916 404964 405147 Impella 5.5 with SmartAssist Set, US (0550-0008) Serial Numbers: 313711 313730 313762 313780 316678 317849 319440 320326 320332 320593 321229 321274 323883 323887 323958 324062 324151 324292 324328 324340 324342 325116 326264 326320 326529 329919 331667 331668 332082 332086 333730 333743 333761 334699 334702 336068 336775 336788 338606 338638 339419 339647 339723 340789 341182 341992 342461 342463 342685 342901 342903 343302 344979 345850 347527 348215 348613 349427 349642 349644 349646 349648 349668 350162 351174 351312 352938 352939 353150 354051 355116 355118 356497 356505 356516 356520 357004 357019 357021 357154 357156 357282 357801 357802 358264 358582 358823 360276 361205 361618 361620 361621 361700…
FDA’s list runs to 5,114 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.
US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
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.
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 Apr 17, 2023.
- FDA classified it on May 18, 2023.
- FDA’s Enforcement Report published it on May 24, 2023.
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 5,114 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.