Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. 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 Product
- 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 to Do
On December 12, 2024, Abiomed Inc. sent all affected customers an Urgent Medical Device Correction notification recommending 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.
Reason for Updates to Use Instructions
Abiomed Inc. has updated the use instructions for the Impella RP with SmartAssist and Impella RP Flex with SmartAssist due to 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.
There have been no reported injuries. There have been no reports of death.
Device Use
The Impella RP Flex with Smart Assist System Catheter is used for up to 14 days in patients that develop acute right heart failure after left ventricular assist device implantation. The device is placed via the internal jugular vein and supports the right chamber of the heart (ventricle) by pumping blood into the pulmonary artery.
Contact Information
Customers in the U.S. with questions about this recall should contact Abiomed at onemd-field-actions@its.jnj.com.
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database Entries
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.