Medtronic recalls specific lots of GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94115T) due to potential sterile barrier breach. Affected units include certain lot numbers and GTINs.
Certain lots of product have the potential for a sterile barrier breach.
Medtronic is recalling specific lots of their GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94115T) because some units may have a sterile barrier breach. This could lead to infection risks during medical procedures.
The sterile barrier breach could allow contaminants to enter the bloodstream during surgery, potentially causing infections. This risk is specific to certain production lots and does not affect all units.
Patients undergoing cardiopulmonary bypass surgery using this specific cannula model are most at risk. Healthcare providers using the recalled product may also be affected.
Check for the model number 94115T on the cannula. Affected units have specific lot numbers listed in the recall notice, including GTINs 00643169454521 and 20643169454525.
Look for the model number 94115T and the specific lot numbers listed in the recall notice.
The recall states a potential sterile barrier breach in certain lots, which could lead to infection risks during medical procedures. This is not a hazard for normal use outside of surgical contexts.
Check for the model number 94115T and the specific lot numbers listed in the recall notice, including GTINs 00643169454521 and 20643169454525.
The recall does not specify a stop-use action; affected units should be checked against the listed lot numbers to determine if they are included.
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-2215-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2215-2026 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.
