The Recall Desk
HighFDA (Devices)·Z-2041-2021·Announced 2021-07-14

Medtronic CoreValve Evolut R Delivery Catheter System Recalled for Actuator Separation

Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.

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: FDA Class II recall for documented device malfunction (actuator separation) in a critical cardiac catheter system. The source does not report specific hospitalizations or patient injuries, but actuator separation represents a significant risk of harm in a cardiac delivery device.

Plain-English summary

Medtronic Heart Valves Division is recalling CoreValve Evolut R Delivery Catheter Systems (model numbers ENVEOR-L and ENVEOR-N) due to reports of actuator separation in the delivery systems.

The recall affects 67,339 units manufactured before July 11, 2020, distributed globally including all U.S. states, Puerto Rico, and numerous other countries. Specific lot numbers have been identified for both device models.

Patients and healthcare providers who have these devices should contact their healthcare provider immediately regarding the recall. Healthcare facilities should review the affected lot numbers and discontinue use of recalled batches per Medtronic's instructions.

The recalled product

Product
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Manufacturer
Medtronic Heart Valves Division
Category
Medical Device — Cardiac Device
Hazard
Affected units
67,339

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 (18)

  • 0010204030
  • 0010209069
  • 0010209070
  • 0010279048
  • 0010281657
  • 0010289860
  • 0010296299
  • 0010199874
  • 0010209064
  • 0010211942
  • 0010253924
  • 0010258778
  • 0010260161
  • 0010262936
  • 0010289861
  • 0010296302
  • 0010297110
  • 0010301887

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Heart Valves Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Medtronic Heart Valves Division

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Same hazard · actuator separation

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