Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code

FDA device recall Z-0980-2024 · posted 2024-02-09 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

Action taken

Firm notified affected consignees of the updated warnings in the IFU beginning on December 27, 2023. Customers were provided with details of the IFU modifications. Customers should notify everyone at their facility who needs to be informed of this correction. If products have been forwarded to another facility, please notify that facility of the updated IFUs. Post a copy of the recall notice in a visible area for awareness. If you have questions or concerns regarding this notice, please contact recallcoordinators@abiomed.com and/or your local clinical field staff.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

OZD

Quantity affected

91,914 (65,857 US; 26,075 OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.

Date initiated

2023-12-27

Date posted

2024-02-09

Location

Danvers, MA