Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Reported: September 11, 2024 Initiated: August 5, 2024 #Z-2961-2024
Product Description
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
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.
Details
- Recalling Firm
- Abiomed, Inc.
- Units Affected
- 1,889 units
- Distribution
- 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.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;. Recalled by Abiomed, Inc.. Units affected: 1,889 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2024. Severity: Moderate. Recall number: Z-2961-2024.
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