Home / Recalls / ev3 Inc. / Z-0450-2022

Z-0450-2022 Class I Terminated

Recalled by ev3 Inc. — Plymouth, MN

FDA device recall Z-0450-2022 was initiated by ev3 Inc. on December 6, 2021 and is designated Class I. 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. The recall status is terminated (terminated October 2, 2024). Affected quantity: 71,260 units.

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
71,260 units

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.

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-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.

Other recalls by ev3 Inc.

  • Z-0904-2025 Class II — Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0500 (December 10, 2024)
  • Z-0694-2022 Class I — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalo (February 4, 2022)
  • Z-0695-2022 Class I — Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalo (February 4, 2022)
  • Z-0451-2022 Class I — Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S- (December 6, 2021)
  • Z-3055-2020 Class II — Pacific Xtreme (PTCA Balloon Dilation Catheter) (August 26, 2020)
  • Z-2048-2016 Class II — EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene (May 23, 2016)
  • Z-1552-2016 Class II — ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Ster (March 29, 2016)
  • Z-0879-2015 Class II — ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx o (December 4, 2014)
  • Z-0878-2015 Class II — ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx o (December 4, 2014)
  • Z-1489-2014 Class II — ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: A (April 9, 2014)

FDA data resources