Medtronic Perfusion Systems medical device recall: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96259
- Recall initiated
- Feb 5, 2025
- Classified by FDA
- Mar 13, 2025
- Posted in Enforcement Report
- Mar 19, 2025
- Recalling firm
- Medtronic Perfusion Systems
- Firm location
- Brooklyn Park, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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).
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 5, 2025. FDA classified it 36 days later, on Mar 13, 2025. Distribution reported by FDA: 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… Medtronic Perfusion Systems has 38 recalls in our records.
Recalled products (1)
Z-1306-2025 Class I Ongoing
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
Codes / lots: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 i. UDI-DI 00613994495457, lots 2022050698 2022070054 2023040161 2024040471 2024040475 2024051027 2024051028 ii. UDI-DI 00673978175959, lots 2022050698 2022060347 2022061333 2022081070 2023020720 2023030372 2023031531 2023100234 2023100235 2023120484 2024030256 2024040475 iii. UDI-DI 20613994495451, lots 2022020438 2022030157 2022030297 2022030478 2022030747 2022040309 2022040902 2022050053 2022050697 2022050698 2022060347 2022061333 2022070054 2022070055 2022081070 2022081428 202209C071 202211C054 2023020719 2023020720 2023030372 2023031531 2023040161 2023040433 2023040806 2023041172 2023050066 202305C067 202307C101 2023100087 2023100234 2023100235 2023100489 2023100490 2023100876 2023111145 2023111146 2023120073 2023120484 2023120485 202312C018 2024011341 2024011342 2024011344 202401C303 202401C304 2024020238…
Quantity: 316,205
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96259
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.