Impella 5.5 Pump Labeling Updated Due to Device Interaction
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a potential device-device interaction during coronary interventions with no reported illnesses or injuries. The hazard is theoretical, and the remedy is a labeling update, placing this in the high category for precautionary recalls without documented harm.
Plain-English summary
Abiomed, Inc. is updating the instructions for use (IFU) for the Impella 5.5 SmartAssist Set, a cardiac mechanical support device, to address a potential interaction with another medical device. The potential interaction may occur when the Impella pump is positioned on the left side of the heart during coronary interventions that use the Shockwave Coronary IVL Catheter.
Abiomed initiated this recall because the current labeling did not include information about this potential device-to-device interaction. The updated labeling will document the interaction risk to inform clinicians and healthcare providers using these devices.
The recall affects 788 units of the Impella 5.5 SmartAssist Set (Product Code 1000211) that have been distributed worldwide. No illnesses or injuries have been reported in connection with this potential device interaction.
Healthcare facilities and interventional cardiology teams using the Impella 5.5 should review the updated labeling when released. Clinicians should be aware of this potential interaction when considering combined use of these devices in coronary intervention procedures.
The recalled product
- Product
- Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device
- Hazard
- device-interaction
- missing-labeling
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 (2)
- Product Code: 1000211
- UDI-DI: 00813502012453
Distribution
Distributed nationwide across the United States.
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