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
Check against the official notice below — it lists the full affected range.
Medtronic is recalling the HawkOne Directional Atherectomy System (catalog numbers H1-S and H1-S-INT) used for small vessel procedures. The recall was initiated because reports showed the device's tip can become damaged during use, which in some cases led to tip detachment and embolization (migration of material into the bloodstream). Approximately 28,094 units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as to numerous countries in Europe, Latin America, Asia, Africa, and the Middle East.
The recall affects devices with specific lot and code numbers from manufacturing facilities in Irvine and Galway. The source document does not specify what remedy or action affected consumers should take.
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: 28,094 units Lot/code info: H1-S - Irvine GTIN 00643169792319, Galway GTIN 00643169968356. H1-S-INT, Irvine GTIN 00643169728790, Galway GTIN 00643169968530.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.