Impella Controller
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Impella Controller |
Software V6.0.1–6.0.3 and ≥7.1 |
0042-0040-CA |
Impella Controller |
Software V6.0.1–6.0.3 and ≥7.1 |
0042-0000-CA |
Issue
Abiomed, Inc. has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.
Additional information
Details
| Abiomed Inc. |
| 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923 |
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