Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommend
Summary
The FDA issued a Class I for Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S- by ev3 Inc.. Reason: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization..
Details
Source
Device Recall
External ID
Z-0451-2022
Action Date
2022-01-26
Status
Terminated
Category
device
Product Description
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 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.
Lot/Code Info: H1-S - Irvine GTIN 00643169792319, Galway GTIN 00643169968356. H1-S-INT, Irvine GTIN 00643169728790, Galway GTIN 00643169968530.
Quantity Affected: 28,094 units
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 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Plymouth, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ev3 Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ev3 Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ev3 Inc. have FDA actions?
ev3 Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0451-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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