The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries 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
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart (ventricles) when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy.
Reason for Recall
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 a purge leak occurs the system will experience low purge pressures, prompting alarms and requiring evaluation. 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 serious injury or death.
Abiomed reports 179 complaints, three injuries and no deaths related to this recall.
Who May be Affected
- People who receive ventricle and circulatory support from Impella 5.5 with SmartAssist.
- Health care personnel providing care for people who receive support using the Impella 5.5 with SmartAssist.
What to Do
On April 17, 2023, Abiomed sent an Urgent Medical Device Recall letter to customers. The letter included the following recommended actions for customers and users:
- Examine inventory immediately to determine if you have product subject to this recall.
- Do not use affected products unless no other product is available.
- Contact Abiomed customer support to coordinate product return according to a scheduled date.
- Review the Important Information included in the letter for best practices in the event you must use these devices while you wait for a replacement, which includes:
- Prior to implant, ensure the Impella Sidearm Retainer is in place.
- Sterilization solutions which contain isopropyl alcohol (IPA) (e.g., ChloraPrep, Hibiclens, IPA wipes, IPA caps, Stryker Sage 2% Chlorhexidine Gluconate, 3M Duraprep) should never be applied to the Impella sidearm and purge filter, per the Instructions for Use (IFU).
- A Codan Extension Tubing Set should be used to support delivery of sodium bicarbonate purge solution. For maximum effectiveness, the extension tubing set should be installed dry to the yellow Luer on the Impella 5.5 purge sidearm at the beginning of the case and should not be disconnected or replaced for the duration of the case.
- Purge cassette changes can be performed less frequently (purge cassettes have been tested with bicarbonate for 5 days).
- Review importance of three-point fixation of the sidearm as per the IFU.
- Refer to Section 8 in the IFU that describes purse system events and the High Motor Current events, and the communications Abiomed previously issued:
- Technical Bulletin: Reminder of Impella 5.5 with SmartAssist Best Practices for Purge Management, April 2020
- Product Update: Heparin-Free Purge for All Impella Pumps, October 2022
- Review, complete all fields, sign, and return the Business Response Form (BRF) on the last page of the letter to the Recall Coordinator.
- Forward this notice to any personnel in your facility who need to be informed.
- Provide a copy of this notice to the relevant personnel at facilities that may have been forwarded the affected devices.
- Post a copy of this notice in a visible area for awareness.
Customers with questions about this recall should contact Abiomed’s Clinical Support Center at 1-800-422-8666.
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 using an online form, regular mail, or FAX.