Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 100030
See all recalls from Abiomed, Inc. →Recalled Product
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for ImpellaCP SmartAssistSetAPAC, Delo1895; Product →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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