Recall Z-2962-2024— Abiomed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abiomed, Inc., initiated 2024-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;. Reason: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-05
- Firm location
- Danvers, MA, United States
Product description
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Reason for recall
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.