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
Check against the official notice below — it lists the full affected range.
Medtronic HawkOne Directional Atherectomy System devices with catalog numbers H1-M and H1-M-INT have been recalled due to reports of tip damage during use, which in some cases resulted in tip detachment and embolization. The recall affects 71,260 units distributed worldwide, including across the United States and Puerto Rico, as well as to numerous international locations.
The source document does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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, Port Quantity: 71,260 units Lot/code info: H1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.