EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 183,964 EverFlex Self-Expanding Peripheral Stents with Entrust Delivery Systems distributed worldwide. The recall addresses potential harms related to partial stent deployment during use. All lot codes of multiple model variants are affected, spanning various sizes and configurations of the stent system.
The company has updated the Instructions for Use to provide a manual deployment workaround method to help mitigate the risks associated with partial stent deployment. The recall record does not specify a remedy or recommended actions for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Reason for recall: Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment. Distribution: worldwide Quantity: 183964 devices Lot/code info: All Lot codes: 1) Model Number EVX35-08-060-120, GTIN 00763000052355; 2) Model Number EVX35-05-020-080, GTIN 00763000051655; 3) Model Number EVX35-05-020-120, GTIN 00763000051662; 4) Model Number EVX35-05-020-150, GTIN 00763000051679; 5) Model Number EVX35-05-040-080, GTIN 00763000051686; 6) Model Number EVX35-05-040-120, GTIN 00763000051693; 7) Model Number EVX35-05-040-150, GTIN 00763000051709; 8) Model Number EVX35-05-060-080, GTIN 00763000051716; 9) Model Number EVX35-05-060-120, GTIN 00763000051723; 10) Model Number EVX35-05-060-150, GTIN 00763000051730; 11) Model Number EVX35-05-080-080, GTIN 00763000051747; 12) Model Number EVX35-05-080-120, GTIN 00763000051754; 13) Model Number EVX35-05-080-150, GTIN 00763000051761; 14) Model Number EVX35-05-100-080, GTIN 00763000051778; 15) Model Number EVX35-05-100-120, GTIN 00763000051785; 16) Model Number EVX35-05-100-150, GTIN 00763000051792; 17) Model Number EVX35-05-120-080, GTIN 00763000051808; 18) Model Number EVX35-05-120-120, GTIN 00763000051815; 19) Model Number EVX35-05-120-150, GTIN 00763000051822; 20) Model Number EVX35-05-150-080, GTIN 00763000051839; 21) Model Number EVX35-05-150-120, GTIN 00763000051846; 22) Model Number EVX35-05-150-150, GTIN 00763000051853; 23) Model Number EVX35-06-020-080, GTIN 00763000051860; 24) Model Number EVX35-06-020-120, GTIN 00763000051877; 25) Model Number EVX35-06-020-150, GTIN 00763000051884; 26) Model Number EVX35-06-040-080, GTIN 00763000051891; 27) Model Number EVX35-06-040-120, GTI
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.