Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Certain lots of product have the potential for a sterile barrier breach.
Medtronic is recalling certain lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913) because some units could 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 during cardiopulmonary bypass procedures. Patients undergoing surgery with this device may be at risk of infection if the sterile barrier is compromised.
Check for the model number 94913 on the device. Affected units have specific lot numbers listed in the recall notice, including 0231757977 through 0232114667 and other codes like C232276641.
Look for the model number 94913 on the device's label to confirm if it's affected.
The recall indicates potential risk of sterile barrier breach, but the device is generally safe if used correctly with the correct model and lot numbers.
Check the device model and lot numbers against the list provided in the recall notice to determine if it's affected.
The recall notice does not specify a replacement process or remedy for affected units.
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-2219-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2219-2026 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.
