Z-0561-2021 Class II Terminated
FDA device recall Z-0561-2021 was initiated by Medtronic Heart Valves Division on October 23, 2020 and is designated Class II. Reason for recall: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). The recall status is terminated (terminated November 22, 2022). Affected quantity: 19,961 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- October 23, 2020
- Termination Date
- November 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,961 units
Product Description
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 EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
Reason for Recall
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Distribution Pattern
Worldwide 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, Norway, Egypt, Saudi Arabia.
Code Information
All GTINs and associated serial numbers (refer to Attachment A-Product List as of 22-Oct-2020).