Every recall we track for Medtronic Heart Valves Division — 7 in all — plus the complaints and injury reports the public filed about them.
Medtronic recalls Harmony Delivery Catheter Systems with specific lot numbers due to potential distal tip detachment during procedures. Affected units may require replacement to prevent complications.
Medtronic recalls CoreValve Evolut PRO PLUS Delivery Catheter Systems made before July 11, 2020 due to reported actuator separation. Affected units include specific model numbers and lot numbers listed in the recall notice.
Medtronic recalls CoreValve Evolut R Delivery Catheter Systems made before July 11, 2020 due to reported actuator separation. Affected models include ENVEOR-L and ENVEOR-N with specific lot numbers.
Medtronic recalls CoreValve Evolut PRO Delivery Catheter Systems (manufactured before July 11, 2020) due to reported actuator separation. Affected units include specific model numbers and lot numbers listed in the recall notice.
Medtronic recalls Evolut R System heart valves with model numbers EVOLUTR-23 to EVOLUTR-34. Potential for valve leaflet damage during post-implant balloon dilatation may cause complications.
Medtronic recalls Evolut PRO+ System models EVPROPLUS-23US to EVPROPLUS-34US due to potential TAV leaflet damage during balloon dilatation. Affected patients should contact Medtronic for guidance.
Medtronic recalls Evolut PRO System models EVOLUTPRO-23 to EVOLUTPRO-29 for potential valve leaflet damage during post-implant balloon dilatation, which could affect heart valve function.
