International safety notice
Delivery catheter system that is a component of the Core Valve Evolut R, Core Valve Evolut PRO, and Evolut PRO+ systems. It has been reported that the handle part (actuator) of a system (hereinafter referred to as "DCS") separated during use (sales (Incidence rate of 0.18% with approximately 270,000 units sold worldwide from launch to March 2021). May occur during valve loading, during insertion of the DCS, and during deployment or repositioning of the biological valve.. In S, the possibility of a similar event occurring cannot be denied, so we have decided to voluntarily recall the affected lot products. We have decided to implement the following.
Japan / PMDA Recalls · JPN · Jun 10, 2021
Key facts
| Title | Delivery catheter system that is a component of the Core Valve Evolut R, Core Valve Evolut PRO, and Evolut PRO+ systems. It has been reported that the handle part (actuator) of a system (hereinafter referred to as "DCS") separated during use (sales (Incidence rate of 0.18% with approximately 270,000 units sold worldwide from launch to March 2021). May occur during valve loading, during insertion of the DCS, and during deployment or repositioning of the biological valve. . In S, the possibility of a similar event occurring cannot be denied, so we have decided to voluntarily recall the affected lot products. We have decided to implement the following. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Transcatheter porcine heart valve Sales name: (1) Core valve Evolut R (2) Core valve Evolut PRO (3) Evolut PRO+ system |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | D-EVPROP34US, 0010296301, 0010289861, 0010296299, 0010289862, D-EVPROP2329US, 0010289860, 0010296302, 0010271292, 0010291593, 0010171869, 0010294653 and 3 more |
| Date | Jun 10, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1