FDAFDA · Food and drugs·Recall number Z-2956-2024
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Published September 11, 2024 · Recall initiated: August 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.
- Lot
- Product Code: 0048-0034-JP; UDI-DI: 00813502011463; Serial Numbers: 324303 323153 328083 328085; Batch Numbers: 2022079852 2022079846 2022083745 2022083747
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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