“Abiomed Impella 5.5 with SmartAssist: Purge Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58548-abiomed-impella-5-5-with-smartassist-purge-leak-risk. Based on FDA recall #Z-1590-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1590-2023%22&limit=1).
Abiomed, Inc. voluntarily recalled the Impella 5.5 with SmartAssist catheter on April 17, 2023, according to the FDA. The device faces a heightened complaint rate for purge leaks.
How to tell if you have it
Brand: Abiomed
Product: Impella 5.5 with SmartAssist catheter
Product Numbers: 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Units affected: 610
The hazard
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since September 4, 2019. Other recent recalls of similar products include the Stryker BARD Dynamic XT Deca Steerable Catheter Recall (April 10, 2026) and the Medline medical procedure kits with Strykeflow 2 irrigation leak risk recall (December 16, 2025).
How to tell if you have this one
Check if your Impella 5.5 catheter has the product numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), or 0550-0008 (Impella 5.5 with SmartAssist Set, US). Look for the specific serial numbers listed in the recall notice.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify your Impella 5.5 catheter's product number and serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1590-2023 (April 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1590-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.