Abiomed, Inc. recalls Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
See all recalls from Abiomed, Inc. →Recalled Product
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
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: 0048-0034-JP; UDI-DI: 00813502011463; Serial Numbers: 324303 323153 328083 328085; Batch Numbers: 2022079852 2022079846 2022083745 2022083747
✅ 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 Set, →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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