FDA Medical devices recall · March 19, 2025

Aortic Root Cannula: 1. DLP Aortic Root Cannula A… recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

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

Why was it recalled?

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 should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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 202402C163 2024030255 2024030256 2024030692 2024040471 2024040472 2024040473 2024040474 2024040475 2024040476 2024040575 2024051027 2024051028 2024051029 202406C113 202406C114 202407C087 2024100440 2024100441 ***ADDED 6/27/25*** SN 0230896975 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 i. UDI-DI 00613994495488, lots 2022070410 2023041174 2023080113 2023080118 2024040576 ii. UDI-DI 00673978175997, lots 2022050367 2022050702 2022060276 2022070411 2022071072 2022110378 2022110379 2023020394 2023040163 2023050068 2023051166 2023080118 2023080721 2024010419 2024010566 2024030694 2024030965

Distribution

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

States: Georgia Puerto Rico

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-1306-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.