This recall involves correcting certain 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
The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Automated Impella Controllers be corrected prior to continued use.
Affected devices:
| Product Description | Product Code | UDI-DI |
|---|---|---|
| Impella Controller, Packaged, US | 0042-0000-US | 00813502010022 |
Full List of Affected Serial Numbers
What to Do
Work with Abiomed to correct affected products. Hospital inventory can continue to be used.
On April 20, Abiomed sent all affected customers a letter recommending the following actions:
- The Abiomed servicing team will contact facilities with affected devices to coordinate the return of the device(s) to implement necessary changes. To ensure continuity of care, hospital inventory can continue to be used.
- Upon contact from Abiomed’s field servicing team, please work with them to return the identified device(s) for the change to be implemented.
- Forward to anyone in your facility that needs to be informed, such as 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.
Reason for Correction
Abiomed identified AIC units that require specific hardware updates to address potential safety concerns during a retrospective review of servicing records. These hardware updates are intended to mitigate risks that could potentially lead to a delay or loss of hemodynamic support, which in turn may result in serious injury or death.
| Issue | Hardware Update |
|---|---|
| The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. | Installation of a Twist-Lok cable retention device to hold the Video Graphics Array cable away from the Digital Signal Processor chipset. |
| There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data-logging issues. | Add a Compact Flash Memory Card Retainer to ensure proper seating of the flash card and prevent dislodgement. |
| Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. | Add a wire clip that ensures proper fan wire routing and prevent cable pinch/shorting. |
| Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single-fan fuse failures. | Add a new Power Battery Manager printed circuit board assembly with improved on-board components (capacitors and fuses). |
All four of the above-mentioned issues could lead to a failure to boot the controller or a sudden interruption in hemodynamic support. In all cases, the console would have to be exchanged for a replacement device, additionally delaying patient treatment. Delay or loss of hemodynamic support can have different consequences depending on the vulnerability and hemodynamic dependency of the supported patient and may lead to serious injury or death.
As of April 14, Abiomed has not reported any serious injuries or 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 real time catheter position information regarding the location of the catheter across the aortic valve.
Contact Information
Customers in the U.S. with questions about this recall should contact Abiomed at [email protected].
Additional FDA Resources:
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.