Medtronic recalls specific left heart vent catheter models due to potential unsealed sterile packing. Affected units include various model numbers and lot numbers from 2023. Consumers should check their device details and contact Medtronic for guidance.
Potential for unsealed sterile packing.
Medtronic is recalling several left heart vent catheter models because they might have unsealed sterile packaging. This could lead to contamination or infection if the device is used without proper sterilization. Affected models and lot numbers are listed in the recall notice.
The sterile packaging may become unsealed during manufacturing or shipping, potentially allowing contamination. If the catheter is used without proper sterilization, it could lead to infection or other complications.
Patients using the recalled left heart vent catheters are most at risk. These devices are typically used in hospitals for heart conditions and are not sold to the general public.
Check for model numbers 12001, 12008, 12010, 12012, 12016, 12002, 12113, or 12220 with specific lot numbers listed in the recall notice. The devices were sold starting in 2023.
Look for the model number and lot number on the device packaging or label to determine if it is affected.
The recall is due to a potential risk of unsealed sterile packaging, which could lead to contamination if the device is used without proper sterilization.
Check the model number and lot number on your device. Affected models include 12001, 12008, 12010, 12012, 12016, 12002, 12113, or 12220 with specific lot numbers listed in the recall notice.
No immediate stop is required. The recall is for potential contamination risk, not an active hazard in normal use. Check the device details and contact Medtronic for guidance.
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-1797-2024 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1797-2024 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.
