Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR F
FDA device recall Z-1306-2025 · posted 2025-03-13 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- 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).
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 316,205
- Distribution
- Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And He
- Date initiated
- 2025-02-05
- Date posted
- 2025-03-13
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L (K100274) | Medtronic, Inc. | 2010-05-10 |