Z-2957-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2024
- Initiation Date
- August 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
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.
Distribution Pattern
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.
Code Information
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