Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Summary
The FDA issued a Class I for Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Num by Abiomed, Inc.. Reason: A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling cent.
Details
Source
Device Recall
External ID
Z-2281-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Lot/Code Info: UDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540
Quantity Affected: 166 units
Reason for Recall
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
Distribution
US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-29
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 202 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-2281-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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