Medtronic recalls Everflex Self-Expanding Peripheral Stents with Entrust Delivery System due to potential label length mismatch. Affected models include EVD35-07-060-120 and EVD35-07-120-120. Contact Medtronic for details.
Stent length on the label may not match the length of the stent itself.
Medtronic is recalling Everflex Self-Expanding Peripheral Stents with Entrust Delivery System because the label may not match the actual stent length. This mismatch could lead to improper placement during medical procedures, potentially causing complications.
The stent label may not match the actual length, which could result in improper placement during medical procedures. This might cause complications such as blockages or inadequate treatment of the affected artery.
Patients who have received the recalled stents for peripheral artery treatment are affected. Medical professionals using these stents in procedures are at risk of incorrect placement.
Check for model numbers EVD35-07-060-120 or EVD35-07-120-120 on the stent packaging. The recall includes specific lot numbers and unique device identifiers (UDIs) listed in the product description.
Verify the model number on the stent packaging to see if it matches EVD35-07-060-120 or EVD35-07-120-120.
The recalled models are EVD35-07-060-120 and EVD35-07-120-120.
Check the model number on the stent packaging; affected models include EVD35-07-060-120 and EVD35-07-120-120.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0188-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0188-2018 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.
