Medtronic Perfusion Systems: Medical Device Recall in 2024 - (Recall #: Z-0289-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Product Classification:

Class II

Date Initiated: October 3, 2024

Date Posted: November 13, 2024

Recall Number: Z-0289-2025

Event ID: 95507

Reason for Recall:

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Status: Ongoing

Product Quantity: 420 units

Code Information:

UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304

Distribution Pattern:

US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

Voluntary or Mandated:

Voluntary: Firm initiated