Abiomed is recalling specific Impella 5.5 with SmartAssist sets after receiving customer complaints about purge fluid leaking from the purge sidearm of the pump. If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to death.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

• Product Name: Impella 5.5 with SmartAssist

• Product Code: 0550-0008

• Product Serial Numbers: See Recall Database Entry

• Distribution Dates: September 28, 2021 to March 6, 2023

• Devices Recalled in the U.S.: 466

• Date Initiated by Firm: April 17, 2023

Abiomed reports 179 complaints, three injuries and no deaths related to this recall. Customers with questions about this recall should contact Abiomed’s Clinical Support Center at 1-800-422-8666.

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 using an online form, regular mail, or FAX.

Read more of this medical device recall on FDA website here.

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

▪ Submit a Report Online:

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

▪ Send a Report Via U.S. Mail or Fax:

Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms-reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.