The Recall Desk
HighFDA (Devices)·Z-1644-2022·Announced 2022-09-07

Medtronic EverFlex Peripheral Stents Recalled for Partial Deployment Risk

Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA medical device recall for risk-of-harm product. Partial stent deployment represents potential for serious injury in critical vascular applications. No adverse events reported in source material. Meets rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System, manufactured by Medtronic Inc., is subject to a worldwide Class II recall affecting multiple model numbers and configurations of the device.

The recall addresses potential harms related to partial stent deployment, where the stent may not fully expand during the placement procedure. Proper device function depends on complete deployment in the vascular system.

Mediatronic has issued an updated Instructions for Use (IFU) containing a manual deployment workaround method to mitigate these risks. Healthcare providers and patients with implanted devices should review the updated instructions and consult with their medical team regarding any devices already placed. For questions or device replacement options, contact Medtronic.

The recalled product

Product
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Manufacturer
Medtronic Inc.
Category
Medical Device — Vascular Stent
Hazard
  • partial-deployment
  • stent-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

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