# FDA recall Z-0559-2021

> **Medtronic Heart Valves Division** · Class II · device recall initiated 2020-10-23.

## 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 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 EVOLUTR-23-US TAV 23 US COMM MX;      b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX;      c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX;      d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX  VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX,  LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM 

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0559-2021
- **Recalling firm:** Medtronic Heart Valves Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-16
- **Termination date:** 2022-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Ana, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0559-2021

## Citation

> AI Analytics. FDA recall Z-0559-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0559-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*