FDA recall, , High risk
Impella CP Set with SmartAssist
Impella CP Set with SmartAssist can cause low purge pressure alarms and loss of circulatory support.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, recalled the Impella CP Set with SmartAssist because exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. The recall, begun May 18, 2026, affects 10 units distributed in the US to Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington and Wisconsin, and internationally to Czech Republic, Norway and Japan.
The FDA added the recall to its Enforcement Report and classified it on June 18, 2026, with the weekly enforcement report published June 24, 2026. Product codes include 1000080, 1000851, 0048-0014 and 0048-0024-JP.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Match the UDI-DI and product code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Impella CP Set with SmartAssist.
- UDI-DI
- 00813502012279
- Product code
- 1000080
- 1000851
- 0048-0014
- 0048-0024-JP.
Recall details
- Company began the recall
- Sold in
US distribution to Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington, Wisconsin. International distribution to Czech Republic, Norway, and Japan
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98946
- Recall number
- Z-2457-2026
- Quantity recalled
- 10 units
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
