Food, drugs, devices › ev3 Inc.
Device recall: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommen
FDA enforcement event 89229 is a device recall by ev3 Inc. of Plymouth, MN, initiated 6 Dec 2021 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 2 Oct 2024. Initiation: voluntary: firm initiated. ev3 Inc. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ev3 Inc., Plymouth, MN.
Reason for recall
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0450-2022 | 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 intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for… | 71,260 units | Class I | Terminated | 26 Jan 2022 |
| Z-0451-2022 | 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 intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for… | 28,094 units | Class I | Terminated | 26 Jan 2022 |
Context
Other enforcement events for ev3 Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Dec 2024 | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W05002 | Device | Class II | 1 |
| 4 Feb 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral va | Device | Class I | 2 |
| 26 Aug 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Device | Class II | 1 |
| 23 May 2016 | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Pr | Device | Class II | 1 |
| 29 Mar 2016 | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. | Device | Class II | 1 |
| 4 Dec 2014 | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patie | Device | Class II | 2 |
| 9 Apr 2014 | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Oct 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.