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Open, Classified

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

FDA Recall Z-0289-2025 · Posted 2024-11-04

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-10-03
Product Quantity420 units

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

Firm Action

Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K790565AORTIC ROOT CANNULADlp, Inc. · 1979-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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