Aortic Root Cannula: 1 — Class I medical device recall Z-1306-2025
Ongoing recall by Medtronic Perfusion Systems, reported 2025-03-19, distributed nationwide. Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harm
| Recall number | Z-1306-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-03-13 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KY, LB, LT, LU, LV, MA, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 316,205 |
| UPC / GTIN / UDI-DI | 00613994495396, 00613994495402, 00613994495457, 00613994495464, 00613994495488, 00613994495495, 00673978175959, 00673978175997, 00673978178325, 00673978178356, 20613994495390, 20613994495406, 20613994495451, 20613994495468, 20613994495482, 20613994495499 |
| Lot numbers | 0230309138, 0230454264, 0230554218, 0230554221, 0230554222, 0230604770, 0230689091, 0230689287, 0230848408, 0230848409, 0230848410, 0230848424, 0230848506, 0230896975, 0230897437, 0230897438, 0230897439, 0230897440, 0230897441, 0230897454, 0230897458, 0230897484, 0230924990, 0230924993, 2022010947, 2022010948, 2022010949, 2022011031, 2022011033, 2022011174, 2022020079, 2022020081, 2022020084, 2022020086, 2022020088, 2022020091, 2022020094, 2022020438, 2022020439, 2022020440 and 460 more |
| Model numbers | 11012, 11012L, 11014, 11014L, 21012, 21014 |
Product
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1306-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.