Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall for a precautionary labeling update to address a potential device interaction during coronary interventions. Although no adverse events have been reported in the source material, the recall is justified as a risk-of-harm product where the interaction, if unrecognized during high-risk coronary interventions, could lead to serious patient harm.
Plain-English summary
Abiomed, Inc. is recalling the Impella 5.5 with SmartAssist S2 Set to update device labeling related to a potential device interaction. The recalled devices involve a potential interaction between the Impella pump and the Shockwave Coronary IVL Catheter during coronary interventions. Currently, Abiomed's labeling and instructions for use do not contain information about this potential interaction.
Abiomed will update the instructions for use to include information on this device interaction. The recall affects 11,576 units distributed worldwide, including the United States and numerous countries internationally. Healthcare providers should be aware that updated product labeling will address this interaction risk.
The recalled product
- Product
- Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 11,576
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: 1000100
- UDI-DI: 00813502012828
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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