Medtronic recalls EverFlex Self-Expanding Peripheral Stents with Entrust Delivery System due to potential partial deployment risks. Affected models include 158 specific model numbers and GTINs.
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Medtronic is recalling EverFlex Self-Expanding Peripheral Stents with Entrust Delivery System because an update to the user manual provides a workaround for partial deployment issues. This recall affects 158 specific model numbers and GTINs.
The stent may not deploy fully during medical procedures, which could lead to complications. The update to the user manual offers a manual deployment method to address this issue.
Patients who have received this stent during medical procedures are most at risk. The recall applies to specific model numbers and GTINs used in the device.
Check the model number and GTIN on the device. Affected models include 158 specific model numbers and GTINs listed in the recall notice.
Check the device's user manual for the latest deployment instructions to ensure safe use.
The recall addresses a potential risk of partial deployment, but the update to the user manual provides a manual deployment workaround to mitigate this issue.
Check the model number and GTIN on your device against the 158 specific model numbers and GTINs listed in the recall notice.
No, the recall does not require stopping use; instead, it provides a manual deployment method to address potential partial deployment issues.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1644-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1644-2022 from Medtronic. 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.
