The Recall Desk
HighFDA (Devices)·Z-2043-2021·Announced 2021-07-14

CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation

Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.

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: No illnesses or injuries have been reported. However, the potential for actuator separation to compromise valve deployment in a critical cardiac procedure represents a significant risk of harm in this high-risk medical device application.

Plain-English summary

Medtronic Heart Valves Division is recalling the CoreValve Evolut PRO PLUS Delivery Catheter System worldwide due to reports of actuator separation. The recall affects 67,339 units globally that were manufactured before July 11, 2020.

The delivery catheter system is used during valve implantation procedures to position and deploy the prosthetic heart valve. The actuator controls the deployment mechanism. Separation of the actuator could prevent proper valve placement during the procedure.

The affected systems include model numbers D-EVPROP2329US and D-EVPROP34US, with specific lot numbers identified by Medtronic. These devices were distributed throughout the United States, Puerto Rico, and to more than 50 countries worldwide. Healthcare providers with affected lot numbers should contact Medtronic for instructions on managing inventory and replacement options. Patients who have received these devices should contact their healthcare provider for guidance.

The recalled product

Product
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Manufacturer
Medtronic Heart Valves Division
Category
Medical Device — Cardiac delivery system
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)

  • 0010165310
  • 0010165312
  • 0010165313
  • 0010169462
  • 0010169464
  • 0010171866
  • 0010171868
  • 0010171869
  • 0010173361
  • 0010175293
  • 0010175294
  • 0010181410
  • 0010181411
  • 0010181412
  • 0010182735
  • 0010182736
  • 0010188541
  • 0010192246
  • 0010192247
  • 0010197788

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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