FDA Device recall Z-1590-2023
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numb…
- FDA Device
- Class I
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class I recall of Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numb… by Abiomed, citing the Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1590-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-04-17 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abiomed |
| Distribution | US |
Product
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)
Reason
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Identifiers
| code_info | Impella 5.5 JP(1000211) Serial Numbers: 368476 375832 379587 379685 381256 381255 381642 385162 385180 385179 385641 38…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 40 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1590-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.