Medtronic Heart Valves Division recalls
Every recall we track for Medtronic Heart Valves Division — 7 in all, from 2020–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
7 recalls since 2017.
All FDA recall records for Medtronic Heart Valves Division since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 3 | 0 | 0 | 3 |
| 2021 | 0 | 3 | 0 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
What to do if you have a recalled Medtronic Heart Valves Division product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Heart Valves Division recalls
3 shown- Use cautionMedical device
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
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.
MedtronicMay 22, 2026 - Use cautionMedical device
Medtronic Heart Valves Division recalls CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
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.
MedtronicJun 11, 2021 - Use cautionMedical device
Medtronic Heart Valves Division recalls Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L
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.
MedtronicOct 23, 2020
Medtronic Heart Valves Division recall questions
How many recalls has Medtronic Heart Valves Division had?
7 recalls from Medtronic Heart Valves Division are on record with U.S. safety agencies, from 2020–2026.
What is the most recent Medtronic Heart Valves Division recall?
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System, dated May 22, 2026. Every Medtronic Heart Valves Division recall is listed on this page, newest first.
What should I do if I have a recalled Medtronic Heart Valves Division product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Heart Valves Division recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.