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

FDA device recall Z-1074-2024 · posted 2024-02-12 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

Action taken

On December 27, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the IFU update, which included a New Warning: "To reduce the possibility of fibers being drawn into the Impella, customers should avoid exposing the inlet and cannula section of the Impella Heart Pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers." The IFU udpate also includes updates to Potential Adverse Events and Warnings to add potential of cardiac or vascular injury. That part of the recall is classified and tracked under RES 93749. Customers should review the IFU updates and send their response form to the recalling firm. Please forward the recall notice to all impacted parties at your facility as well as any facilities to whom subject product has been forwarded. Post a copy of the notice in a visible area for awareness. Customers with questions may contact recallcoordinators@abiomed.com.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

OZD

Quantity affected

92515

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

2024-02-12

Location

Danvers, MA