CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
The FDA is aware that Abiomed has issued a letter to affected customers recommending all Automated Impella Controllers be removed from where they are used or sold. Affected devices:
| Product Description | Product Code | UDI-DI |
|---|---|---|
| Impella Controller, Packaged, US | 0042-0000-US | 00813502010022 |
| Impella Optical Controller, Packaged, US | 0042-0010-US | 00813502010985 |
| Optical, AIC, Impella Controller, Pkgd, US | 0042-0040-US | 00813502011401 |
What to Do
While awaiting replacement from Abiomed, hospital inventory can continue to be used to ensure continuity of care. In the event of purge flag component failures and associated alarms, reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller.
On August 12, Abiomed sent all affected customers a letter recommending the following actions:
- In the event of these purge flag component failures and associated alarms, as per IFU, first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller.
- Improper cleaning can cause damage to plastic components including the purge flag. Ensure cleaning of the AIC housing with mild detergent as specified in the IFU.
- Ensure future routine preventive maintenance is performed annually on your AIC(s) following the guidance in the IFU.
- All AIC units globally are in scope of this removal, and as such, a phased removal approach is being implemented.
- Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care.
- Abiomed’s field service team will contact you to schedule the specified replacement. Please work with them to return the identified device(s) to implement replacement of the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC.
- Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products).
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
- Post a copy of this notice in a visible area for awareness.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Abiomed is removing Automated Impella Controllers (“AICs”) due to purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly. The purge flag engages with the purge disc and allows the AIC to recognize that the purge disc is inserted properly.
Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. Implementation of this replacement will be done through annual preventative maintenance or individual outreach by Abiomed’s service team. Abiomed will contact you to coordinate scheduling of the removal.
If a purge flag component failure were to occur during set up of clinical procedure, the user would see a “Purge Disc Disconnected” alarm on the AIC. As per the Instructions for Use (IFU), first reinsert the purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. Refer to below for an example of the alarm:
If a purge flag component failure were to occur during hemodynamic support, the user would see a “Purge Disc not Detected” alarm on the AIC. As per the Instructions for Use (IFU), first reinsert the purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. Refer to below for an example of the alarm:
Exposure to these AIC purge flag component failures requires an AIC exchange to solve the issue. If the failure occurs before support is started, there may be a delay to the procedure. In cases involving hemodynamic instability, this delay may result in a prolonged period without mechanical circulatory support.
If the failure occurs during active Impella support, it will usually occur during an elective exchange of the purge cassette, but may also happen during ongoing support. In the case of ongoing support, mechanical circulatory support will continue while purge delivery is stopped and the AIC exchange is planned. While urgent, exchange of the AIC can be prepared for, including additional hemodynamic stabilization of the patient for the brief interruption of support.
As of August 17, Abiomed has reported 37 serious injuries and three deaths associated with this issue.
Device Use
The Automated Impella Controller is the primary user control interface for the Impella Catheter. It controls the Impella Catheter performance, monitors the catheter for alarms, and provides catheter position information regarding the location of the catheter across the aortic valve.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Abiomed at (978) 646-1400 or OneMD-Field-Actions@its.jnj.com.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved 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.
