CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report
Evolut (TM) R System recalled by Medtronic Heart Valves
Medtronic Heart Valves Division is recalling Evolut (TM) R System, distributed nationwide in the US. The recall was initiated on 23 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0559-2021
- FDA event ID
- 86681
- Recalling firm
- Medtronic Heart Valves Division, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2020
- FDA classified
- 10 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2020 | Recall initiated by company | |
| 10 Dec 2020 | Classified by FDA | +48 days |
| 16 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Product as listed by the FDA
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 OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Which lots are affected?
All GTINs and associated serial numbers (refer to Attachment A-Product List as of 22-Oct-2020).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 86681This product is part of a recall event; the main page for the event is Evolut (TM) PRO System recalled by Medtronic Heart Valves.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Evolut (TM) PRO System recalled by Medtronic Heart Valves | Medtronic Heart Valves Division | Other | Nationwide | |
| CLASS II | Evolut (TM) PRO+ System recalled by Medtronic Heart Valves | Medtronic Heart Valves Division | Other | Nationwide |
More recalls from Medtronic Heart Valves Division
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medtronic Harmony Delivery Catheter System recalled | Medtronic Heart Valves Division | Other | Nationwide |
| Device | CLASS II | CoreValve Evolut PRO PLUS Delivery Catheter System recalled | Medtronic Heart Valves Division | Other | 48 states |
| Device | CLASS II | CoreValve Evolut R Delivery Catheter System recalled | Medtronic Heart Valves Division | Other | 48 states |
| Device | CLASS II | CoreValve Evolut PRO Delivery Catheter System recalled | Medtronic Heart Valves Division | Other | 48 states |
| Device | CLASS II | Evolut (TM) PRO+ System recalled by Medtronic Heart Valves | Medtronic Heart Valves Division | Other | Nationwide |
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