Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 26, 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 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
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
ev3 Inc. recalled Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Mul… - a critical-severity action.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Mul… was recalled by ev3 Inc. in January 26, 2022. Reason: Reports have been received of tip damage during use of the devices which resulted in some instances of tip de…. Check the official notice for the remedy. Verify recall #Z-0450-2022 with the FDA Devices before acting.
The recall
ev3 Inc. issued this critical-severity FDA Devices recall-Reports have been received of tip damage during use of the devices which resulted in some instances of tip de….
- Critical
- severity level
- 71K units
- affected scope
- Class I
- classification
- January 26, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0450-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0450-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on December 6, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. ev3 Inc. is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 71,260 units.
The documented reason for this recall is: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. Distribution data in the federal record shows the product reached: 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, E…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
71,260 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0450-2022 |
| Date reported | January 26, 2022 |
| Date initiated | December 6, 2021 |
| Recalling firm | ev3 Inc. |
| Firm location | Plymouth, MN |
| Affected scope | 71,260 units |
| 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, Finla… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0450-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ev3 Inc.. Units affected: 71,260 units.
Why was this product recalled? ▼
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Critical. Recall number: Z-0450-2022.
Where was the recalled product distributed? ▼
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, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0450-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 26, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.