Plymouth, MN, United States
ev3 Inc. recalls
4 recalls recorded since 2018, most recently on 10 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 10 December 2024
- Reason
- There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
- Distribution
- Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0904-2025
- Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14
Terminated Class I Medical devices
- Recall started
- 4 February 2022
- Terminated
- 2 October 2024
- Reason
- The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0695-2022, Z-0694-2022
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
- Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Terminated Class I Medical devices
- Recall started
- 6 December 2021
- Terminated
- 2 October 2024
- Reason
- Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
- Distribution
- Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israe
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0450-2022, Z-0451-2022
- Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is i
- Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is int
Terminated Class II Medical devices
- Recall started
- 26 August 2020
- Terminated
- 9 June 2023
- Reason
- Labeling discrepancy for the Rated Burst Pressure (RBP) value.
- Distribution
- Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3055-2020
- Pacific Xtreme (PTCA Balloon Dilation Catheter)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.