Medtronic recalls specific lots of GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94113T) due to potential sterile barrier breach. Affected units may compromise infection control during medical procedures.
Certain lots of product have the potential for a sterile barrier breach.
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94113T) because they may have a sterile barrier breach. This could lead to infection risks during medical procedures if the device is used improperly.
The sterile barrier breach could allow contaminants to enter the device, potentially causing infections during medical procedures. This risk is specific to the device's use in cardiopulmonary bypass surgeries where sterile conditions are critical.
Healthcare professionals using the device for cardiopulmonary bypass procedures are most at risk. Patients receiving these procedures may be affected if the device is used on them.
Check for the model number 94113T on the device. Affected units have specific lot numbers listed in the recall notice, including 0231651336 and others.
Look for the model number 94113T on the silicone body of the cannula.
Confirm if your device has any of the listed lot numbers: 0231651336, 0231651345, 0231651385, etc.
The recall is due to potential sterile barrier breaches in certain lots of the device, which could lead to infection risks during medical procedures.
Check for the model number 94113T and verify if your lot number matches the list provided in the recall notice.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2214-2026 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2214-2026 from Medtronic. 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.
