CLASS I Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Medtronic HawkOne Directional Atherectomy System recalled by ev3
ev3 is recalling Medtronic HawkOne Directional Atherectomy System, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class I.
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-0450-2022
- FDA event ID
- 89229
- Recalling firm
- ev3, Plymouth, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 19 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 19 Jan 2022 | Classified by FDA | +44 days |
| 26 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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 use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
Where it was distributed
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, Israel, Italy, Jordan, Korea, Republic Of Macao, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, and United Kingdom.
Questions about this recall
Why was it recalled?
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Which lots are affected?
H1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.
Where was it sold?
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, Israel, Italy, Jordan, Korea, Republic Of Macao, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, and United Kingdom.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
1 other product · FDA event 89229| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Medtronic HawkOne Directional Atherectomy System recalled by ev3 | ev3 | Other | Nationwide |
More recalls from ev3
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic NanoCross Elite PTA catheter recalled by ev3 | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic TurboHawk Plus Directional Atherectomy System 6F recalled | ev3 | Other | Nationwide |
| Device | CLASS I | Medtronic HawkOne Directional Atherectomy System recalled by ev3 | ev3 | Other | Nationwide |
| Device | CLASS II | Pacific Xtreme (PTCA Balloon Dilation Catheter) recalled by ev3 | ev3 | Other | 42 states |
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