Reported May 24, 2023 · Ongoing
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory…
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 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
- Lot codes and dates
- Impella 5.5
- JP(1000211) Serial NumbersImpella 5.5
78 of 78 codes
368476375832379587379685381256381255381642385162385180385179385641385666385671385674386036386037386045386058386128386133386134386132386138386143386149386147387492387498385548385546385549387509387506404248404251387526404272387502387501387503387518387515387532387825405172405171405170405175405173405176405177406161406342404263406171406170405464405472405471405704
- Smart Assist (0550-0002) Serial NumbersImpella 5.5 with SmartAssist Set
92 of 92 codes
321271333003333035333043334696345239360280360511365273365274367019367021370130370129375223375221375671381808381809384612384834397290394926395381398208398567403771403886403884404028397198397200397284397281397295397294397291397309397307397310397306397499397496397500397498403114407858407868407873407872407234408363408365408572411385411444412012412360412359413091
- US (0550-0008) Serial Numbers
537 of 537 codes
313711313730313762313780316678317849319440320326320332320593321229321274323883323887323958324062324151324292324328324340324342325116326264326320326529329919331667331668332082332086333730333743333761334699334702336068336775336788338606338638339419339647339723340789341182341992342461342463342685342901342903343302344979345850347527348215348613349427349642349644
- Amount recalled
- 610 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
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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