The Recall Desk

FDA (Devices) recall action 86681

Medtronic Heart Valves Division recalled 3 products on 2020-12-16

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-12-16
Critical
0
Units
263,842

Why these products were recalled

Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2020-12-16

    Medtronic Evolut PRO System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling 71,030 Evolut PRO System units worldwide due to a potential for transcatheter aortic valve leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-16

    Medtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk

    Medtronic is recalling 19,961 Evolut PRO+ Transcatheter Aortic Valve systems due to a potential for leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV E
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-12-16

    Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT
    Category
    Distribution
    0 states