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)

Class I - Dangerous

🏥 Medical Devices Recalled: April 17, 2023 Abiomed Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
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 361944 361948 362181 362183 362208 362464 363035 363868 363878 363885 364664 365297 365680 366500 367423 367685 367988 369142 369144 369148A 369688 369689 369694 370328 370824 370984 371079 371170 371730 372056 372272 372297 372444 372445 372683 372705 372740 373080 373633 373884 373907 374650 374940A 375113 375117 375667 375675 376117 376366 376399 376660 376919 376923 377128 377422 377689 377887 377888 378424 378598 378662 379047 379059 379077 379969 379976 380201 381332 381613 381769 381785 381787 381826 382015 382017 382658 382766 383194 383220 383235 383496 383498 383734 384072 384087 384698 384723 384797 384803 384849 387009 387042 387051 387055 387246 387249 387265 387271 387308 387337 387830 387854 388058 388062 388064 388072 388077 388286 388287 388288 388298 388607 388608 388617 388619 388629 388630 389103 389104 389105 389120 389316 389317 389753 389884 389885 390346 390368 390521 390883 391210 391212 391237 391291 391422 391582 391585 391586 391745 391858 391892 391907 392194 392234 392247 392248 392251 392414 392488 392489 392684 392737 392868 392876 392911 392913 392955 393030 393045 393142 393298 393323 393327 393353 393369 393379 393385 393386 393387 393610 393615 393740 393743 393796 393804 393903 393911 394144 394150 394288 394314 394401 394452 394494 394605 394612 394625 394735 394816 394866 394867 394955 394957 395259 395264 395476 395484 396478 396493 396494 396498 396502 396577 396588 396767 396768 396769 396811 396813 396827 397039 397040 397041 397046 397054 397127 397133 397201 397440 397468 397469 397780 397782 397843 397847 397850 397993 398012 398127 398128 398152 398153 398155 398239 398240 398241 398315 398478 398483 398484 398497 398499 398502 398544 398581 398585 398739 398740 398741 398906 399010 399060 399424 399425 399467 400351 400379 400395 400413 400414 400473 400480 400488 400492 400689 400691 400732 400734 400735 401387 401395 401396 401447 401453 401455 401458 401459 401485 401607 401609 401611 401619 401621 401635 401700 401706 401709 402262 402263 402281 402288 402291 402469 402697 402709 402713 402739 402783 402785 402888 402918 402928 403085 403089 403486 403489 403818 403820 403821 404438 404439 404680 405162 405164 405165 405166 405222 405608 405609 405613 405617 405629 405630 405720 405721 405722 405961 406393A 406635 406658 406659 406754 406769 406770 406781 406988 406994 406996 407240 407241 407246 407516 407578 407579 407581 407645 407657 407662 407750 407958 408107 408471 408472 408475 408547 408549 408589 408881 409045 409058 409073 410978 410995 410997 411192 411195 411196 411197 411203 411239 411284 411456 411460 411593 411678A 411836 411838 411990 412015 412019 412036 412037 412211 412213 412216A 412217A 412488 412490 412632 412790 412802 412803 412880 412881 413108 413121 413124 413269 413349 413378 413379 413380 413514 413517 413649 413799 413856 413857 413858 413926 413928 414202 414228 414461 414465 414524 414526 414699 414700 414701 414713 415142 415187 415191 415214 415216 415267 415268 415285 415322 415494 415497 415501 415515 415571 415934 415936 415966 416032 416066 416071 416752 416794A 416798
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Abiomed, Inc.
Reason for Recall:: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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)

Product Codes/Lot Numbers:

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 361944 361948 362181 362183 362208 362464 363035 363868 363878 363885 364664 365297 365680 366500 367423 367685 367988 369142 369144 369148A 369688 369689 369694 370328 370824 370984 371079 371170 371730 372056 372272 372297 372444 372445 372683 372705 372740 373080 373633 373884 373907 374650 374940A 375113 375117 375667 375675 376117 376366 376399 376660 376919 376923 377128 377422 377689 377887 377888 378424 378598 378662 379047 379059 379077 379969 379976 380201 381332 381613 381769 381785 381787 381826 382015 382017 382658 382766 383194 383220 383235 383496 383498 383734 384072 384087 384698 384723 384797 384803 384849 387009 387042 387051 387055 387246 387249 387265 387271 387308 387337 387830 387854 388058 388062 388064 388072 388077 388286 388287 388288 388298 388607 388608 388617 388619 388629 388630 389103 389104 389105 389120 389316 389317 389753 389884 389885 390346 390368 390521 390883 391210 391212 391237 391291 391422 391582 391585 391586 391745 391858 391892 391907 392194 392234 392247 392248 392251 392414 392488 392489 392684 392737 392868 392876 392911 392913 392955 393030 393045 393142 393298 393323 393327 393353 393369 393379 393385 393386 393387 393610 393615 393740 393743 393796 393804 393903 393911 394144 394150 394288 394314 394401 394452 394494 394605 394612 394625 394735 394816 394866 394867 394955 394957 395259 395264 395476 395484 396478 396493 396494 396498 396502 396577 396588 396767 396768 396769 396811 396813 396827 397039 397040 397041 397046 397054 397127 397133 397201 397440 397468 397469 397780 397782 397843 397847 397850 397993 398012 398127 398128 398152 398153 398155 398239 398240 398241 398315 398478 398483 398484 398497 398499 398502 398544 398581 398585 398739 398740 398741 398906 399010 399060 399424 399425 399467 400351 400379 400395 400413 400414 400473 400480 400488 400492 400689 400691 400732 400734 400735 401387 401395 401396 401447 401453 401455 401458 401459 401485 401607 401609 401611 401619 401621 401635 401700 401706 401709 402262 402263 402281 402288 402291 402469 402697 402709 402713 402739 402783 402785 402888 402918 402928 403085 403089 403486 403489 403818 403820 403821 404438 404439 404680 405162 405164 405165 405166 405222 405608 405609 405613 405617 405629 405630 405720 405721 405722 405961 406393A 406635 406658 406659 406754 406769 406770 406781 406988 406994 406996 407240 407241 407246 407516 407578 407579 407581 407645 407657 407662 407750 407958 408107 408471 408472 408475 408547 408549 408589 408881 409045 409058 409073 410978 410995 410997 411192 411195 411196 411197 411203 411239 411284 411456 411460 411593 411678A 411836 411838 411990 412015 412019 412036 412037 412211 412213 412216A 412217A 412488 412490 412632 412790 412802 412803 412880 412881 413108 413121 413124 413269 413349 413378 413379 413380 413514 413517 413649 413799 413856 413857 413858 413926 413928 414202 414228 414461 414465 414524 414526 414699 414700 414701 414713 415142 415187 415191 415214 415216 415267 415268 415285 415322 415494 415497 415501 415515 415571 415934 415936 415966 416032 416066 416071 416752 416794A 416798

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1590-2023

Related Recalls

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

Abiomed

Class I - Dangerous

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Sep 16, 2025 Other Medical Devices Nationwide View Details →

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.

Abiomed

Class I - Dangerous

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Oct 1, 2025 Infusion Pumps Nationwide View Details →

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.

Abiomed

Class I - Dangerous

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

Aug 20, 2025 Infusion Pumps View Details →