Z-0451-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- October 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,094 units
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.
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 Pattern
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.
Code Information
H1-S - Irvine GTIN 00643169792319, Galway GTIN 00643169968356. H1-S-INT, Irvine GTIN 00643169728790, Galway GTIN 00643169968530.