Impella RP Recall
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February 15, 2025
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Justin
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The Impella RP Recall: Updates to the Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist
We are litigating Impella recall cases, and there are several Impella heart pump recalls. Today, we’re writing about the recall FDA announced in February 2025.
What is the Impella Heart Pump?
The Impella heart pump is a medical device that helps the heart pump when a medical condition causes problems with its natural ability to do so. There are several types: Impella 2.5p, Impella 5.5 with SmartAssist, and Impella RP with SmartAssist.
The Impella RP Recall
A medical device recall can involve several things. It may involve a removal from market, which is less common than the name recall might suggest. Many times it means changing the instructions for use, which are essentially the directions for the surgeons using the device.
This recall involves updating instructions for using certain Impella devices. It does not involve removing them from the market. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Impella Heart Pump Devices
These are the specific Impella pumps covered by this Impella recall. Put simply, this is an Impella RP recall.
- Product Names: Impella RP with SmartAssist and Impella RP Flex with SmartAssist
- Unique Device Identifier (UDI)/Model: 00813502011869 and 00813502012811
- Lot/Serial Numbers: All devices
What is the Impella RP Recall?
On December 12, 2024, the company responsible for the Impella, Abiomed Inc., sent customers an Urgent Medical Device Correction notificationExternal Link Disclaimer. Per FDA’s notice, it recommends the following actions:
- Product is NOT being removed from the field and does not need to be returned.
- Forward this notice to anyone in your facility that needs to be informed.
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
- Use updated instructions for use, found in the Urgent Medical Device Correction notification, when inserting, manipulating, or removing concomitant devices.
What is the Impella Recall Updating the Use Instructions?
Abiomed Inc. updated the use instructions for the Impella RP with SmartAssist and Impella RP Flex with SmartAssist because of a risk that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment, or removal. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop. This may trigger alarms and cause a loss of certain heart and blood pressure readings.
Have Patients Reported Injuries from this Impella RP Recall?
Per FDA’s February 14, 2025 note, there have been no reported injuries. There have been no reports of death. That’s a good thing and we hope it stays that way. Any patients or loved ones who believe otherwise, should contact us at 855-KBA-LAWS (522-5297) or Intake@KBAattorneys.com.
An Impella Recall by Any Other Name: Other Impella Recalls
This is not the first Abiomed Impella recall. We represent clients concerning another Abiomed Impella heart pump recall. An Impella recall of interest to our firm is the Abiomed Impella recall 2023. Check out our other pages for more information about the FDA Impella recall.
The Impella Heart Pump – an Abiomed Impella Recall and Impella Lawsuit
We have written about the Impella recall in other pieces as well.
FDA Announces Major Recall of Impella Heart Pumps for High Injury Risk
