Reported Jun 24, 2026 · Ongoing
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Impella CP Set with SmartAssist
- Product Codes
100008010008510048-00140048-0024-JP
- Lot codes and dates
- GTIN00813502012279
- Product Codes (Serial Number)
1000080 (677223672986673252644591645428644314613525)1000851 (636173)0048-0014 (499250)0048-0024-JP (661216)
- Amount recalled
- 10 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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