FDAFDA recall Z-2457-2026 · Jun 24, 2026
Abiomed, Inc.: Impella CP Set with SmartAssist recall
Recall found
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
- Quantity
- 10 units
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Recalling firm
- Abiomed, Inc., Danvers, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-18
Source: openFDA enforcement record Z-2457-2026 · search recall number Z-2457-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.