Reported Sep 7, 2022 · Ongoing
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
- EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
- Lot codes and dates
158 of 158 products
Products covered by this recall Model / number Product as published 00763000052355Model Number EVX35-08-060-120 00763000051655Model Number EVX35-05-020-080 00763000051662Model Number EVX35-05-020-120 00763000051679Model Number EVX35-05-020-150 00763000051686Model Number EVX35-05-040-080 00763000051693Model Number EVX35-05-040-120 00763000051709Model Number EVX35-05-040-150 00763000051716Model Number EVX35-05-060-080 00763000051723Model Number EVX35-05-060-120 00763000051730Model Number EVX35-05-060-150 00763000051747Model Number EVX35-05-080-080 00763000051754Model Number EVX35-05-080-120 00763000051761Model Number EVX35-05-080-150 00763000051778Model Number EVX35-05-100-080 00763000051785Model Number EVX35-05-100-120 00763000051792Model Number EVX35-05-100-150 00763000051808Model Number EVX35-05-120-080 00763000051815Model Number EVX35-05-120-120 00763000051822Model Number EVX35-05-120-150 00763000051839Model Number EVX35-05-150-080 - Amount recalled
- 183964 devices
Why it was recalled
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
This product could cause temporary or reversible health problems — stop using it.
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