FDA Medical devices recall ·
Impella CP Set with SmartAssist recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2457-2026
- Date
- (initiated May 18, 2026)
- Company / brand
- Abiomed, Inc.
22 Cherry Hill Dr, Danvers, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
Distribution
US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
States: Georgia Iowa Nebraska Pennsylvania Texas Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2457-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.