ClearanceBrief
Recall Z-0559-2021 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered

Medtronic Heart Valves Division

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 R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLU

DateOct 23, 2020
StatusTerminated
ReasonPotential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Root causeLabeling design
ActionOn 10/23/2020, the firm sent an "Urgent Medical Device Correction" Notification Letter to customers via UPS 2-day delivery informing them that the Recalling Firm has received complaint of valve leaflet damage occurring following a post-implant balloon dilatation (PID) resulting in moderate or severe aortic insufficiency which were detected acutely or during follow up. The Recalling Firm has identified the potential cause of the damage which is due to over-expansion of the narrowest portion (waist) of the Transcatheter Aortic Valves (TAVs). The Recalling Firm is also stating that depending on
Quantity172,851 units
DistributionWorldwide distribution - U.S. Nationwide distribution and the countries of Panama, Denmark, Austria, Germany, Finland, Sweden, Colombia, India, Mexico, Brazil, Spain, United Kingdom, Australia, Ireland, Italy, Argentina, Japan, Poland, Russian Federation, Hungary, Kazakhstan, Luxembourg, Portugal, N
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.