ev3 Inc recalls
Every recall we track for ev3 Inc — 6 in all, from 2020–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
6 recalls since 2017.
All FDA recall records for ev3 Inc 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 | 0 | 0 | 1 | 1 |
| 2021 | 0 | 2 | 0 | 0 | 2 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled ev3 Inc 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 ev3 Inc recalls
4 shown- Use cautionMedical device
ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2)
Medtronic recalls specific NanoCross Elite PTA catheters with potential in-vivo balloon deflation issues. Affected units have unique reference numbers and serial codes. Contact Medtronic for details.
MedtronicDec 10, 2024 - Use cautionMedical device
ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral
Medtronic recalls its TurboHawk Plus 6F directional atherectomy system for small vessel use due to tip detachment risk. Affected units have catalog number THP-S and GTIN 007630:00402419.
ev3Feb 4, 2022 - Use cautionMedical device
ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)
Medtronic recalls HawkOne Directional Atherectomy System (H1-M and H1-M-INT) due to tip damage causing detachment and embolization. Affected units sold in specific regions with catalog numbers.
MedtronicDec 6, 2021 - UnratedMedical device
ev3 Inc. recalls Pacific Xtreme (PTCA Balloon Dilation Catheter)
ev3 Inc recalls Pacific Xtreme PTCA Balloon Dilation Catheters with labeling discrepancies for Rated Burst Pressure (RBP) values. Affected models and lots listed. No remedy specified in official notice.
ev3 IncAug 26, 2020
ev3 Inc recall questions
How many recalls has ev3 Inc had?
6 recalls from ev3 Inc are on record with U.S. safety agencies, from 2020–2024.
What is the most recent ev3 Inc recall?
ev3 Inc recalls Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2), dated Dec 10, 2024. Every ev3 Inc recall is listed on this page, newest first.
What should I do if I have a recalled ev3 Inc 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 ev3 Inc 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.