Reported Jul 24, 2024 · Ongoing
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
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. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- Lot codes and dates
- Product No.: 1000080 (REF 0048-0003)
- UDI/DI
00813502012279Lot/Serial No.: Lot 1798046
- Serial numbers
504354504355504356504357504359504360504361504362504363
- Amount recalled
- 9 units
Where it was sold
Why it was recalled
Stop using this product now
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
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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