Medtronic recalls specific aortic root cannulae and cardioplegia needles due to potential unsealed sterile packing. Affected models include DLP 9 Ga (11 Fr) Aortic Root Cannula (Model 24009) and others. Consumers should check model numbers and lot dates.
Potential for unsealed sterile packing.
Medtronic is recalling certain aortic root cannulae and cardioplegia needles because they may have unsealed sterile packaging. This could lead to contamination during medical procedures. Affected items include specific model numbers and lot dates listed in the recall notice.
The sterile packaging for these medical devices may not be properly sealed, which could lead to contamination during surgical procedures. If the packaging is compromised, the devices might not be sterile when used, increasing the risk of infection or other complications.
Healthcare professionals using these medical devices during surgeries are most at risk. Patients receiving these devices as part of cardiac surgery procedures may be affected if the devices are used without proper sterile packaging.
Check for model numbers: 24009 (Aortic Root Cannula), 11316 (Cardioplegia Needle), or 11014L (Aortic Root Cannula with Flow-Guard). Look for lot numbers listed in the recall notice, such as 2023040211 or 2023040854.
Identify the model number on the device (e.g., 24009, 11316, or 11014L) to determine if it is affected.
Check the lot number on the device packaging, which should match the listed lot numbers in the recall notice (e.g., 2023040211).
The recall includes DLP 9 Ga (11 Fr) Aortic Root Cannula (Model 24009), DLP 16 Ga (5 Fr) Cardioplegia Needle (Model 11316), and M+AR 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard (Model 11014L).
Check the model number and lot number on the device packaging. Affected models include 24009, 11316, and 11014L with specific lot numbers listed in the recall notice.
No action is required if your device is not listed in the recall notice.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1800-2024 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1800-2024 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
