This recall involves correcting 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 correction.
Affected Product
| Product Code(s) | Product Description(s) | UDI-DI(s) | Impacted Serial Numbers |
|---|---|---|---|
| 0042-0000-US | Impella Controller, Packaged, US | 00813502010022 | All |
| 0042-0010-US | Impella Optical controller, Packaged, US | 00813502010985 | All |
| 0042-0040-US | Optical, AIC, Impella Connect, Pkgd, US | 00813502011401 | All |
| 1000432 | AIC w/Impella Connect for ECP | 00813502013030 | All |
| 1000201 | Dbl Optical, AIC Impella Connect, Pkg US | 00813502010442 | All |
What to Do
On October 1, Abiomed sent all affected customers a letter recommending the following actions:
- Product is NOT being removed.
- Keep the AIC in a secure environment with restricted access whether in clinical use or not.
- To mitigate the vulnerability risk, your Abiomed field representative will contact you to arrange disabling the AIC from the network. The AIC may continue to be used as intended after it is removed from the network.
- If you elect to initiate disabling of the AIC’s network capabilities prior to an Abiomed field representative contacting you, you must reach out via ra-abm-fieldaction@its.jnj.com or to your local clinical field staff for instructions.
- Review this notice carefully, and forward to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the AIC).
- If the AIC has been forwarded to another facility, contact that facility and provide them with Abiomed’s notice.
- If there is suspicion of a cybersecurity event, report to https://www.productsecurity.jnj.com/
- Abiomed is working on security updates and measures to address these cybersecurity vulnerabilities. More information will be provided when further mitigations are available to be deployed to resume network enablement. Abiomed routinely monitors cybersecurity vulnerabilities and will continue to inform you of significant new information if applicable.
Reason for Alert
Abiomed has identified cybersecurity vulnerabilities that have unacceptable residual risk related to network and physical access that could be compromised and result in uncontrolled risks affecting the Automated Impella Controller (AIC) Operating System. If the identified cybersecurity vulnerabilities are exploited, it may affect the essential performance of the AIC. This may potentially result in loss of device control or unexpected pump stop, which can lead to a loss of hemodynamic support potentially resulting in a life-threatening injury, permanent impairment or death.
To date, no cyberattacks or harm to patients have been reported in relation to the identified vulnerabilities.
Device Use
The Automated Impella Controller is the primary user control interface for the Impella Catheters. It controls the Impella Catheter and monitors the catheter for alarms. Impella therapy aims to reduce the work of the heart and provide support for the circulatory system so the heart has time to recover.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed, Inc. at ra-abm-fieldaction@its.jnj.com or 978-646-1400.
Additional FDA Resources
Additional Company Resources
Company-provided information is posted here by the FDA as a public service.
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 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.
