The Recall Desk
HighFDA (Devices)·Z-2042-2021·Announced 2021-07-14

Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall

Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.

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 medical device recall with reported mechanical defect (actuator separation) but no reported illnesses or injuries. Fits rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Heart Valves Division is recalling CoreValve Evolut PRO Delivery Catheter Systems (model numbers ENVPRO-14-US, ENVPRO-14, ENVPRO-16-US, ENVPRO-16-C, and ENVPRO-16) manufactured before July 11, 2020. A total of 67,339 units were affected globally.

The recall was initiated due to reports of actuator separation in the delivery catheter systems. The actuator is a critical mechanical component; separation could affect proper device function during clinical use.

The affected devices were distributed throughout the United States and to multiple countries worldwide. Specific lot numbers affected by this recall are listed in the official FDA recall notice.

For additional information, refer to the FDA recall notice or contact Medtronic directly.

The recalled product

Product
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
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 (20)

  • 0009688651
  • 0009690887
  • 0009693142
  • 0009716570
  • 0009718679
  • 0009724715
  • 0009735112
  • 0009747816
  • 0009747817
  • 0009769716
  • 0009780304
  • 0009780312
  • 0009813675
  • 0009819798
  • 0009833186
  • 0009833187
  • 0009835584
  • 0009884743
  • 0009903576
  • 0009909651

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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