Abiomed, Inc. recalls Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-
See all recalls from Abiomed, Inc. →Recalled Product
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
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: 0048-0040; UDI-DI: 00813502011739; Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806; Batch Numbers: 2023172492 2023172497 2023172494 2023172500 2023172499 2023255511 2023255513 2023255522 2023255514
✅ 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 Impella CP Pump 371 →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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