Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94215T) 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 15FR (Model 94215T) because they could have a sterile barrier breach. This might lead to infections 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 undergoing surgery with this device could face infection risks if the sterile barrier is compromised.
Check for the model number 94215T on the silicone body. The affected lots include 0231881762, 0231881786, 0231931962, 0231962106, and C233032040. The device is used in cardiopulmonary bypass procedures.
Look for the lot numbers 0231881762, 0231881786, 0231931962, 0231962106, or C233032040 on the device packaging.
The recall states that certain lots have a potential for sterile barrier breach, so affected units should not be used until the remedy is applied.
Check the lot number on the device packaging. If it matches the affected lots listed, contact Medtronic Perfusion Systems for instructions.
The affected devices have the model number 94215T and specific lot numbers: 0231881762, 0231881786, 0231931962, 0231962106, or C233032040.
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-2216-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2216-2026 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.
