Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
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 a Class II FDA recall of cardiac assist devices used in high-risk interventional procedures. Although no injuries or illnesses have been reported, the potential interaction between devices used together during coronary interventions represents a risk-of-harm situation that was previously undocumented.
Plain-English summary
The Impella CP Smart Assist Set is subject to a Class II recall because its labeling did not contain information about a potential interaction with the Shockwave Coronary IVL Catheter when both devices are used during coronary interventions. Abiomed is updating the device's instructions for use (IFU) to document this interaction.
The potential device interaction was not previously identified in the product labeling. Updating the labeling will inform healthcare providers about this interaction when selecting and using devices together during coronary procedures.
Approximately 6,267 units of the Impella CP Smart Assist Set, JP (Product Code 0048-0024-JP), were distributed worldwide. Healthcare providers should review the updated labeling and instructions for use once released by the manufacturer.
The recalled product
- Product
- Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 6,267
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: 0048-0024-JP
- UDI-DI: 00813502011609
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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