Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.

Summary:

Abiomed Inc has updated the use instructions for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist due to a risk that guidewires or other medical devices may interact with the Impella pump during insertion, adjustment, or removal. This interaction could result in optical sensor damage, temporary pump stop, or permanent pump stop, potentially affecting heart and blood pressure readings. While no injuries or deaths have been reported, the FDA has classified this recall as the most serious type. The company is not removing the product from the field but has issued updated instructions to mitigate risks.

Key Takeaways:

  • Risk of Device Interaction: Guidewires or other medical devices may come into contact with the Impella RP pump, leading to sensor damage or pump stoppage.
  • FDA Class I Recall: Although no injuries or deaths have been reported, the FDA has identified this as the most serious type of recall.
  • Updated Use Instructions Issued: Abiomed is not pulling the devices from the field but has provided new guidance to healthcare providers to reduce potential risks.

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. The US Food and Drug Administration has identified this recall as Class I, the most serious type. 

The Impella RP Flex with Smart Assist System Catheter is used for up to 14 days in patients who 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.

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 Dec 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.

Customers in the US with questions about this recall should contact Abiomed at [email protected]. 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.

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