Automated Impella Controllers await four pending hardware safety updates
Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Automated Impella Controller (AIC), product code 0042-0000-US, is being recalled. The action covers 91 units, identified by the serial numbers in the recall notice.
A retrospective review identified AIC units requiring specific hardware updates to address potential safety concerns. The updates have been implemented through Abiomed's servicing process, so controllers that have not received service are still pending them. Four issues are described: the proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset could allow electrostatic discharge coupling into the processor and interrupt motor controls; the Compact Flash memory card could dislodge under external force, causing startup failures and data logging issues; improper routing of the fan wire could damage it and cause console boot-up failure; and capacitor issues on the Power Battery Manager could cause pump stop, purge stop and/or single fan fuse failures. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, including nationwide in the United States across states including California, Connecticut, Florida, Louisiana, Massachusetts, Michigan and Missouri. The controllers are used in hospitals to drive Impella heart pumps.
Facilities should identify affected units using the product code, UDI-DI and serial numbers in the recall notice and follow the servicing instructions issued by Abiomed.
The recalled product
- Product
- Automated Impella Controller (AIC); Product Code: 0042-0000-US;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 0042-0000-US
- UDI-DI: 00813502010022
- Serial Numbers: IC2449
- IC2451
- IC2452
- IC2453
- IC2459
- IC2460
- IC1096
- IC1142
- IC1202
- IC1203
- IC1224
- IC1231
- IC1238
- IC1284
- IC1285
- IC1390
- IC1545
- IC1577
Distribution
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