Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Summary
The FDA issued a Class I for Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart s by Abiomed, Inc.. Reason: Nine (9) Impella CP pumps failed inspection and were inadvertently released..
Details
Source
Device Recall
External ID
Z-2319-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Lot/Code Info: Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.
Quantity Affected: 9 units
Reason for Recall
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Distribution
Domestic only: FL, MA, OH TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-31
Company
Danvers, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 198 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2319-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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