This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Automated Impella Controllers be removed from where they are used or sold:
Product Code(s) |
Product Description(s) |
UDI-DI(s) |
|---|---|---|
0042-0000-US |
Impella Controller, Packaged, US |
00813502010022 |
0042-0010-US |
Impella Optical Controller, Packaged, US |
00813502010985 |
0042-0040-US |
Optical, AIC, Impella Connect, Pkgd, US |
00813502011401 |
1000432 |
AIC w/Impella Connect for ECP |
00813502013030 |
1000201 |
Dbl optical, AIC Impella Connect, Phg US |
00813502010442 |
Full list of affected products.
What to Do
Hospital inventory may continue to be used while awaiting service from Abiomed. Abiomed will collect affected product and perform purge retainer updates.
On September 16, Abiomed sent all affected customers a letter recommending the following actions:
- Hospital inventory may continue to be used.
- Upon contact from Abiomed’s field servicing team, please work with them to return the identified device(s) for the update to be implemented.
- Abiomed identified a design change to correct the AIC purge retainer fixture that will be implemented through device servicing at the Abiomed Service Center.
- 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 subject products).
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
- Review, complete all fields, sign, and return the attached business response form.
- As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting Program as per below instructions:
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 Early Alert
Abiomed identified Automated Impella Controller purge pressure issues due to purge retainer failures, such as cracks. Abiomed determined that the force users apply during purge disc insertion/removal contributes to the purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the Automated Impella Controller may need to be replaced. Purge retainer failures may result in a pump stop with resultant loss of hemodynamic support. Loss of hemodynamic support poses a serious risk to patient health and may lead to permanent impairment or death.
As of August 27, Abiomed has reported five serious injuries and no deaths associated with this issue.
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's left ventricle 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 at ra-abm-fieldaction@its.jnj.com.
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.
