Mivi Neuroscience recalls Super 90 8F Guide Catheters with possible pouch seal defects that could lead to nonsterility. Affected units include specific model numbers and expiration dates.
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Mivi Neuroscience is recalling Super 90 8F Guide Catheters that may have a pouch seal defect causing nonsterility. This could lead to infections or contamination during medical procedures. The recall affects specific model numbers and expiration dates.
The catheter pouch seal may be defective, leading to nonsterility. This could cause contamination or infection during medical procedures if the catheter is used without proper sterility.
Medical professionals using these catheters for investigational procedures are most at risk. The recall applies to specific model numbers and expiration dates listed in the notice.
Check for model numbers MIA-9095S-IDE or MIA-9090S-IDE with specific expiration dates listed in the recall notice.
Verify the model number and expiration date on the catheter packaging.
The recall is due to a potential defect in the pouch seal that could lead to nonsterility.
Model numbers MIA-9095S-IDE and MIA-9090S-IDE with specific expiration dates.
Check the model number and expiration date on the packaging against the list provided in the recall notice.
We’ve drafted a message you can send Mivi Neuroscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2442-2021 — Mivi Neuroscience Mivi Neuroscience Hello, I own a Mivi Neuroscience that is covered by recall Z-2442-2021 from Mivi Neuroscience. 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.
