Abiomed, Inc.: Device Recall

Recall #Z-2958-2024 · 08/05/2024

Class II: Risk

Recall Details

Recall Number
Z-2958-2024
Classification
Class II
Product Type
Device
Recalling Firm
Abiomed, Inc.
Status
Ongoing
Date Initiated
08/05/2024
Location
Danvers, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
323 units

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.

Product Description

Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

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.

Other Recalls by Abiomed, Inc.

View all recalls by Abiomed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.