Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

FDA Recall Z-1306-2025 · Posted 2025-03-13

Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2025-02-05
Product Quantity316,205

Reason for Recall

Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

Firm Action

Beginning February 5, 2025, the firm began notifying consignees through a formal Urgent Medical Device Recall letter. Impacted customers were instructed to quarantine and return affected product. ***UPDATE*** Beginning 25 June 2025, Medtronic distributed the Urgent medical Device Recall notice via mail courier to existing and newly identified consignees who have received impacted products. Recall scope was expanded to include additional lots.

Root Cause

Process control

Distribution Pattern

Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Georgia Germany Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Moldova, Republic Of Montenegro Morocco Namibia Nepal Netherlands New Zealand North Macedonia NorthernIreland Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Suriname Sweden Switzerland Taiwan Thailand Turkey Ukraine United Arab Emirates United Kingdom Viet Nam Yemen

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100274MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014LMedtronic, Inc. · 2010-05-10

Official Source

View FDA Recall →

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

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