Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall

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

• actuator-separation

Is your product affected?

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

Distribution

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